Loading clinical trials...
Loading clinical trials...
African Americans (AAs) have a higher risk of developing type 2 diabetes than the general population. AAs are also more likely to eat foods that contain cholesterol oxides/oxysterols. Dietary oxysterols can harm the cells that produce insulin and decrease insulin production. This pilot study seeks to determine if removing dietary oxysterols with a plant-based diet will improve insulin production and decrease the risk of type 2 diabetes among AAs.
African Americans (AAs) have almost twice the incidence and prevalence of Type 2 diabetes (T2D) compared to the general population. T2D occurs when pancreatic β-cell dysfunction prevents secretion of sufficient insulin to overcome insulin resistance. While the causes of β-cell dysfunction are not fully understood, the role of cytotoxic oxidative stress is well documented. Serum oxysterols are biomarkers of oxidative stress. Oxysterols form endogenously or exogenously when cholesterol in food is exposed to light, heat, and processing. Dietary oxysterols are cytotoxic, they are absorbed and carried in the blood by lipoprotein carriers or circulate freely in serum. 7-Ketocholesterol (7-KC), the most common oxysterol in food and serum is a biomarker of cholesterol oxidation. High serum levels of 7-KC are associated with an increased risk of T2D. AAs who consume Southern dietary pattern foods such as fried and processed meats have a higher consumption of dietary oxysterols than the general population. Our central hypothesis is that the higher consumption of dietary oxysterols among AAs contributes to β-cell dysfunction and higher rates of T2D. The aim of this pilot study is to determine the effect of lowering dietary oxysterols on serum 7-KC and β-cell function among AAs with prediabetes and early T2D (HbA1c 5.7% - 7.0%). The expected outcome is that decreased exposure to dietary oxysterols will decrease serum oxysterols and β-cells oxidative stress which will improve β-cell function and glycemic control. The knowledge gained from this study may lead to improved T2D prevention and treatment strategies that may decrease the burden of T2D in all communities and eliminate the racial disparity among AAs.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Morehouse School of Medicine
Atlanta, Georgia, United States
Start Date
July 1, 2021
Primary Completion Date
October 31, 2022
Completion Date
October 31, 2022
Last Updated
October 11, 2021
24
ESTIMATED participants
Plant-based diet with no oxysterols
BEHAVIORAL
Standard ADA Diet (SADA)
BEHAVIORAL
Lead Sponsor
Morehouse School of Medicine
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06671587