The Impact of Consumption of Eggs in the Context of Plant-Based Diets on Endothelial Function, Diet Quality, and Cardio-Metabolic Risk Factors in Adults at Risk for Type 2 Diabetes

Title:The Impact of Consumption of Eggs in the Context of Plant-Based Diets on Endothelial Function, Diet Quality, and Cardio-Metabolic Risk Factors in Adults at Risk for Type 2 Diabetes
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*;Diabetes / Insulin Resistance;Nutrition / Diet
Funding Source:Egg Nutrition Center
Funding Period:2020-2021
Study Design:Randomized, single-blind, controlled, crossover trial
Purpose:People at risk for diabetes are more likely to develop type 2 diabetes, cardiovascular disease, stroke, and hypertension, and to have a higher risk of premature death. To help prevent these conditions, they’re often advised to consume plant-based diets and eat fewer foods from animal sources. However, if they exclude all foods from animal sources, they should plan carefully to get adequate nutrients that are more readily available from animal sources.Eggs provide high-quality protein and are rich in other nutrients that can be low or missing in exclusively plant-based diets. Although eggs are high in dietary cholesterol, recent research has shown that dietary cholesterol may be less likely to raise blood cholesterol levels than previously thought. Therefore, we conducted this study to compare the health effects and diet quality of a plant-based diet versus one combined with eggs.
Further Study Details:This study assessed the impact of including 2 eggs daily for 6 weeks in an otherwise exclusively plant-based diet, compared with a plant-based diet without eggs, on endothelial function (a measure of cardiovascular health), other cardio-metabolic risk factors, and dietary patterns in 35 adults who were at risk for type 2 diabetes.We enrolled 25 women and 10 men, with an average age of 61 years. With guidance from a dietitian, each person followed two variations of a plant-based diet (plant-based only, and plant-based plus 2 eggs per day) in randomly assigned order for 6 weeks each.
Findings:In these adults who were at risk for diabetes, adding 2 eggs daily to an otherwise plant-based diet for 6 weeks had no harmful effects on cardiovascular risk measures, fasting blood glucose, or insulin levels. Adding the eggs led to higher intakes of selenium and choline – two nutrients that are known to be depleted in exclusively plant-based diets. It also led to a small average increase in percent body fat, although body weight did not increase.Based on the results of this small study, eggs could potentially enhance the quality of plant-based diets consumed by adults at risk for type 2 diabetes without increasing their blood glucose or their risk for cardiovascular disease.  A larger study is needed to confirm our findings. More details on this study and its findings were published in the December 2021 issue of The Journal of Nutrition.
Eligibility:Men in the age range of 25 to 75 years, and postmenopausal women up to 75 years old who were not on hormone replacement therapy.  They were also non-smokers and had an increased risk for developing type 2 diabetes based on study criteria.
Evaluation:At different time points, we measured participants’ endothelial function, serum lipids, body composition, body weight, waist circumference, blood pressure, fasting insulin and fasting blood glucose, nutrient intake, and diet quality.

Changed at:12/21/2021 4:28 PMChanged by:
Created at:3/27/2020 2:58 PMCreated by:

Systems Approach to Diabetes Prevention and Management

Title:Systems Approach to Diabetes Prevention and Management
Status:Completed
Topic:Diabetes / Insulin Resistance
Funding Source:Connecticut Health Foundation
Funding Period:2007-2010
Study Design:N/A
Purpose:To enhance both access and quality of diabetes care in underserved communities and to ameliorate health-related disparities. The PRC directed and conducted an overall evaluation of initiatives based in 4 community health centers: Community Health Center, Inc. of Meriden, CT; Community Health Services, Inc. of Hartford, CT; Fair Haven Community Health Center, Inc. of New Haven, CT; and Staywell Health Care, Inc. of Waterbury, CT.
Further Study Details:This study represents a first step in obtaining practice-based evidence for the efficacy for the efficacy of systems change to inform programs and policies at community health centers within the region and at a national level. Participating community health centers submitted proposals to introduce discrete systems change in their practices based on the Chronic Care Model (CCM). The funding enhanced ongoing work to assess the feasibility and efficacy of innovative systems changes targeting populations that carry a disproportionate burden of diabetes.The proposals focused on:improving the quality of diabetes care;expanding and improving access to diabetes preventive and treatment services;contributing to the understanding of diabetes disparities and effective interventions through research, best practices, and evaluation;and increasing and improving racial and ethnic diabetes data collection and analysis
Findings:The four participating health centers implemented diabetes-focused interventions that appropriately relied on the Chronic Care Model. The extent to which elements of the CCM were incorporated into the programs varied from center to center, with a minimum of two elements included at each center. Community Health Center, Inc. had results contrary to expectations: improvements in total cholesterol and hemoglobin A1c (a measure of blood glucose control) in the control group, compared to an increase in total cholesterol and a more modest decrease in hemoglobin A1C in the intervention group. Staywell Health Center, Inc. reported non-significant improvements in diastolic blood pressure and total cholesterol and no changes in other measures from baseline as a result of its intervention (there was no control group). Fair Haven Community Health Center, Inc. reported high numbers of individuals reached, high program participation rates, and successful weight loss and maintenance of weight loss among participants. Community Health Services, Inc. found significant improvements in diastolic blood pressure, diet, and diabetes empowerment, and near significant improvements in other measures. These results suggest that the Chronic Care Model can be used effectively by community health centers to prevent clinical measures predictive of diabetes and diabetesrelated complications, but success is likely highly dependent upon the focus and intensity of the interventions.
Eligibility:N/A

Changed at:1/18/2011 7:19 AMChanged by:Judy Treu
Created at:8/31/2010 10:55 AMCreated by:Griffin Hospital

Post-prandial Effects of High-polyphenolic Extra Virgin Olive Oil on Endothelial Function in Adults at Risk for Type 2 Diabetes: A Randomized Controlled Crossover Trial

Title:Post-prandial Effects of High-polyphenolic Extra Virgin Olive Oil on Endothelial Function in Adults at Risk for Type 2 Diabetes: A Randomized Controlled Crossover Trial
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*;Diabetes / Insulin Resistance;Nutrition / Diet
Funding Source:Centers for Disease Control and Prevention (CDC); Cobram Estate Extra Virgin Olive Oil
Funding Period:2019-2020
Study Design:Randomized, Controlled, Crossover, Double-blind Trial
Purpose:This study compared the after-meal effects of two kinds of olive oil on measures of cardiovascular health in 20 adults (10 men, 10 women) at risk for type 2 diabetes. Diets rich in mono- and polyunsaturated fatty acids have been shown to improve cardiovascular health in people with or at risk for type 2 diabetes. Olive oils have a relatively high content of these fatty acids, with extra virgin olive oil having a significantly higher amount compared to refined olive oil.
Further Study Details:Participants were asked to fast 8 hours prior to testing.  Each participant consumed 2 smoothies (each on a different day) made with fruit and yogurt, and olive oil. Each smoothie was prepared with a different type of olive oil (either high-polyphenolic extra virgin olive oil or refined olive oil. Endothelial function and blood pressure were measured before and 2 hours after consumption of each smoothie.
Findings:High-polyphenolic extra virgin oil acutely enhanced endothelial function in the study cohort, whereas refined olive oil did not.  Blood pressure effects were not observed.
Eligibility:Non-smoking adults between the ages of 25-75 years who were willing to undergo screening for eligibility, visit the PRC three times for assessments, and consume a smoothie that included olive oil during two of these visits.
Evaluation:Endothelial function and blood pressure

Changed at:3/27/2020 3:52 PMChanged by:
Created at:3/27/2020 3:52 PMCreated by:

Photovoice: A Tool for Community Empowerment and Action

Title:Photovoice: A Tool for Community Empowerment and Action
Status:Completed
Topic:Community;Diabetes / Insulin Resistance
Funding Source:Connecticut Health Foundation
Funding Period:2007-2008
Study Design:N/A
Purpose:To use Photovoice to engage people from across the socioeconomic spectrum in calling for New Haven to address issues related to racial health disparities and diabetes.
Further Study Details:Photovoice is a participatory-action research methodology used in public health research to generate discussion among community members and to create prevention and/or intervention strategies. This initiative was focused on identifying the underlying social, economic and environmental issues that make it difficult for local residents to live healthy lifestyles that would help eliminate racial and ethnic health disparities related to diabetes. The project used photography as a vehicle to depict New Haven residents’ concerns about the limited availability of resources to help prevent or manage diabetes. Ten African American women who had previously been trained by the PRC as Community Health Advisors
took photographs in response to questions the research team developed such as “What is missing in this community that would help prevent diabetes?”
Findings:In the fall of 2008, a traveling Photovoice exhibit was featured at several locations in the New Haven community. A reception for the main exhibit at City Hall was held on October 24th. Mayor John DeStefano provided opening remarks, and State Senator Toni Harp spoke about racial and ethnic health disparities in CT. Dr. Forrester Lee, a cardiologist at the Yale School of Medicine, discussed the relationship between lifestyle and heart disease. Other exhibit venues included St. Matthew’s Church, Varick Church, and the Community Outreach Center. The exhibits were viewed by over 250 people, and overall reactions were very positive.Four themes emerged during this process:fear about children’s safety when playing outside;the loss of exercise facilities/resources in the community in recent years;concerns over the high costs of healthful foods; andlimited availability of physicians and dentists to serve underserved and uninsured populations
Eligibility:To qualify for this study, you must:

Changed at:3/1/2017 9:58 AMChanged by:Lisa Seaberg
Created at:8/31/2010 10:52 AMCreated by:Griffin Hospital

Partners Reducing Effects of Diabetes: Initiatives through Collaboration & Teamwork (PREDICT)

Title:Partners Reducing Effects of Diabetes: Initiatives through Collaboration & Teamwork (PREDICT)
Status:Completed
Topic:Diabetes / Insulin Resistance;Faith-based
Funding Source:Connecticut Health Foundation
Funding Period:1/03 – 12/06
Study Design:Community-based Intervention Trial
Purpose:PREDICT was a 3-year collaborative project with the African-American faith-based communities in New Haven and Bridgeport, CT designed to reduce diabetes, and its complications, in those communities.
Further Study Details:In Year 1 of the project, focus groups were conducted to identify knowledge, attitudes, barriers, and determinants of optimal diabetes prevention and management. Community audits were conducted to identify resources within the communities to support the project initiatives. During year 2, the project partnership team applied the findings of year 1 to the development of a tailored community program for New Haven, with Bridgeport serving as the control site. Identified communities in Bridgeport received the intervention, tailored to their needs, the following year. In year 3, the New Haven program was evaluated and the PREDICT partners worked to identify ways in which the successful elements and strategies
of the project could be sustained.
Findings:This controlled trial demonstrated the feasibility of reducing diabetes risk and complications in an urban African-American community using the Community Health Advisor (CHA) model in a Community-based Participatory Research intervention. This study showed that the training program for the CHAs was efficacious. Diabetes knowledge scores of the CHAs improved significantly in New Haven as a result of the 10-week training session. Participants in New Haven exhibited improvements in outcome measures showing a significant improvement in diabetic knowledge from baseline to follow-up. Body mass index decreased from baseline to follow-up among New Haven participants, although not significantly. The results indicate that the intervention group significantly improved their diabetic knowledge, and limited their intake of total calories and trans fats. The CHA model appeared to be a feasible pathway of enhancing diabetic knowledge among the African-American community.
Eligibility:African-American adults diagnosed with or at risk for developing diabetes.

Changed at:3/1/2017 10:29 AMChanged by:Lisa Seaberg
Created at:8/31/2010 11:06 AMCreated by:Griffin Hospital

Novel Interactive Cell phone technology for Health Enhancement (NICHE)

Title:Novel Interactive Cell phone technology for Health Enhancement (NICHE)
Status:Completed
Topic:Diabetes / Insulin Resistance
Funding Source:Confidant, Inc. through funding by NIH
Funding Period:2005-2007
Study Design:Controlled pilot test of feasibility
Purpose:To evaluate the feasibility and efficacy of the Palaistra System (interactive cell phone technology) in the management of type 2 diabetes
Further Study Details:The Palaistra System is a wireless remote patient monitoring and response system, centered around mobile phone technology, that translates scientifically supported knowledge for chronic disease management into action by providing easily followed daily coaching using the patient’s own data. The controlled trial was designed to evaluate the feasibility and efficacy of the Palaistra System in the management of type 2 diabetes.
Findings:The study demonstrated improved levels of glycosylated hemoglobin, positive changes in diabetes management self-efficacy, and diabetes self-care activities among patients in the intervention group who received tailored messages on their cell phones.
Eligibility:Patients in two Community Health Centers (Meriden and New Britain, CT) with type 2 diabetes.

Changed at:1/18/2011 7:22 AMChanged by:Judy Treu
Created at:8/31/2010 10:59 AMCreated by:Griffin Hospital

Health Advocacy for Diabetes Prevention

Title:Health Advocacy for Diabetes Prevention
Status:Completed
Topic:Community;Diabetes / Insulin Resistance
Funding Source:Connecticut Health Foundation
Funding Period:2007
Study Design:N/A
Purpose:To educate residents and community leaders about the devastating effects of diabetes and the dire need for public policies to prevent new cases and to avoid complications among those already diagnosed.
Further Study Details:The study engaged city residents and leaders in a dialogue with election year candidates to learn who among them is committed to work for legislation and adequate financing to seriously address these healthcare issues. The project also aimed to mobilize residents to vote for candidates who support their values on this issue.
Findings:The change ultimately hoped for in the African-American community of New Haven is an informed and vocal electorate that demands adequate health care for all diabetics, a healthy nutritional school environment, and increased opportunities for physical activity for all residents.Specific progress toward this end was planned through the implementation of five strategies:background informationcommunity education/advocacya candidates’ forumparticipation in a “Get Out the Vote” campaignand post-election follow-up with elected officials
Eligibility:African-Americans in New Haven

Changed at:3/1/2017 9:57 AMChanged by:Lisa Seaberg
Created at:8/31/2010 10:57 AMCreated by:Griffin Hospital

Effects of the FOS Biomedical Device on Diabetes Risk Factors and Sleep Quality in Adults at Risk for Type 2 Diabetes: A Randomized, Placebo-controlled, Crossover Trial

Title:Effects of the FOS Biomedical Device on Diabetes Risk Factors and Sleep Quality in Adults at Risk for Type 2 Diabetes: A Randomized, Placebo-controlled, Crossover Trial
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*;Complementary & Alternative Medicine;Diabetes / Insulin Resistance
Funding Source:Fos Biomedical, Inc.
Funding Period:2021-2022
Study Design:Randomized controlled double-blind crossover trial
Purpose:This study tested the effects of a phototherapy product on certain measures of health in people at risk for type 2 diabetes. According to recent research, certain wavelengths of light appear to activate an enzyme in the mitochondria of cells, which in turn appears to activate signaling pathways in the body.  A recent study of mice with diabetes showed that elevated activity of this enzyme led to reduced blood glucose levels and insulin resistance. 
Further Study Details:This study compared the effects of 12 weeks each of a phototherapy patch product vs. placebo patches on markers of cardio-metabolic risk and sleep quality.  The product used 2 small patches worn on the skin that, when activated by body heat, reflected low levels of infrared and visible light to stimulate the skin’s surface.  They did not contain any drugs or herbal compounds, and did not put any chemicals in the body. All tests and study products were provided free of charge.Outcome measures included hemoglobin A1C, insulin sensitivity, serum lipids, C-reactive protein, endothelial function (blood flow measured in the right arm using ultrasound), body composition, and sleep quality. For each of the two treatment periods, measures were assessed at baseline and 12 weeks.
Findings:Data analysis has not been completed.
Eligibility:Adults who met the following criteria:were older than 40 years of age (if women, they must be postmenopausal)were non-smokerswere overweighthad higher-than-normal blood glucose levels, but not diabeteswere willing to do the following over an 8-month period: visit the PRC at Griffin Hospital 5 times for clinical testswear 2 small patches on their abdomen each day for about 6 monthsreport their food and beverage intake on certain days 

Changed at:4/12/2023 4:42 PMChanged by:Christian Meagher
Created at:12/21/2021 12:41 PMCreated by:

Chromium Effects on Insulin and Vascular Function in People at Risk for Diabetes

Title:Chromium Effects on Insulin and Vascular Function in People at Risk for Diabetes
Status:Completed
Topic:Diabetes / Insulin Resistance
Funding Source:National Institutes of Health/NCAMM
Funding Period:11/03 –6/08
Study Design:Randomized, Double-Blind, Placebo-Controlled Modified Crossover Trial
Purpose:To investigate the effects of daily chromium supplementation for 6 months at 2 dose levels on serum measures of glucose tolerance and endothelial function in adults with a higher-than-normal risk of developing diabetes.
Further Study Details:Researchers have been looking for safe, effective, and low-cost ways to prevent and/or treat diabetes. Use of chromium is widespread, but evidence of therapeutic effect is limited. Chromium is a mineral that plays a role in the body’s control of blood glucose, and prior research has suggested that chromium may be helpful in treating Type 2 diabetes. This study examined the effects of chromium on glucose tolerance and endothelial function in people at risk of developing diabetes. The study followed a group of 59 adults (38 women and 21 men) with an average age of 57 years. It investigated the effects of chromium on:blood pressureanthropometric measuresweightwaist circumferencebody mass indexmeasures of diabetes riskfasting glucose levelsinsulin levelsinsulin resistanceoral glucose tolerance testhemoglobin A1c levelsbrachial artery endothelial functionlipid profilestotal cholesterolHDLLDLtriglyceridestotal cholesterol/HDL ratioand urinary measures of microalbumin and the albumin/creatinine ratioParticipants were randomly assigned to a daily dose of either 500 or 1000 micrograms (mcg) of chromium for a period of 6 months. During another 6-month period, each person also received a placebo (inactive substance) for comparison.
Findings:Neither dose (500 mcg or 1000 mcg) of chromium led to any significant changes in any of those measures listed above. During the course of the study, 5 participants developed Type 2 diabetes. Based on results from our study it does not appear that chromium can help prevent or delay Type 2 diabetes. Other recently-published studies also support our findings.
Eligibility:Adult men and women with impaired glucose tolerance, impaired fasting glucose, or insulin resistance.

Changed at:1/18/2011 7:24 AMChanged by:Judy Treu
Created at:8/31/2010 11:04 AMCreated by:Griffin Hospital

A Health Literacy Program to Improve the Prevention of Diabetic Foot Disease in African-American Communities

Title:A Health Literacy Program to Improve the Prevention of Diabetic Foot Disease in African-American Communities
Status:Completed
Topic:Diabetes / Insulin Resistance
Funding Source:Pfizer Health Literacy Initiative
Funding Period:7/02 – 7/04
Study Design:An educational brochure for optimal foot care among patients with diabetes was created in collaboration with clinicians and community educators, and was evaluated through focus groups with diabetic patients. A randomized controlled study was designed to evaluate the efficacy of the brochure among African-American patients with type 2 diabetes.
Purpose:To improve the prevention, and thereby decreasing the incidence and complications, of foot disease in African-Americans patients with diabetes by improving the health literacy of these patients, their families, and their caregivers with regard to diabetic foot care.
Further Study Details:Several focus groups were conducted during Year 1 of the project to guide the development of culturally and educationally appropriate materials to help those at risk prevent and manage foot problems associated with diabetes. The impact of the materials was tested in year 2 when diabetic patients were recruited to participate in the intervention. The outcomes of interest included knowledge, practice, and self-efficacy for proper foot care, as well as general health literacy and presence of foot abnormalities in the study population. Four validated questionnaires and a clinical test for identifying foot abnormalities among patients with diabetes were used to quantify these outcomes at baseline and 3 months later.
Findings:The intervention group had a significant increase over time in general health literacy scores. Positive trends in knowledge, practice and self-efficacy for proper foot self-care were shown but failed to achieve statistical significance. Patients in both groups (intervention and control) experienced positive changes in their knowledge, practice, and self-efficacy for proper foot care. The lack of between-group differences notwithstanding, this study demonstrated the feasibility of developing culturally relevant, educational materials adapted to cultivate health literacy.
Eligibility:African-American men and women diagnosed with diabetes.

Changed at:1/18/2011 9:32 AMChanged by:Judy Treu
Created at:8/31/2010 11:08 AMCreated by:Griffin Hospital