An interventional study of Intensive Lifestyle Intervention (ILI) in Prediabetes, Type 2 Diabetes and Obesity, sponsored by University of Tennessee. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-10-15.
Sponsored by University of Tennessee · Not applicable, Interventional, and Prevention
The reasons for the epidemics of diabetes and prediabetes, and why individuals from certain populations suffer at higher rates are not well known. In the Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) study, nearly 400 African Americans and Caucasians whose parents have type 2 diabetes will undergo repeated testing to determine what factors lead to the occurrence of prediabetes, and whether race still plays a major role in a setting where everyone being studied has one or both parents with diabetes. The PROP-ABC Study also will test the hypothesis that the ability of intensive lifestyle intervention to reverse prediabetes and return people's metabolism back to normal is dependent on how long people have had prediabetes.
The Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) study is following an extant cohort of 376 initially normoglycemic African American and Caucasian offspring of parents with type 2 diabetes for an additional 5years. The subjects were enrolled between 2006 and 2009 and have been followed up to 2012, during which 10 have developed diabetes and 101 developed prediabetes, without evidence of racial disparities.
The objectives of PROP-ABC are to gain a fuller understanding of the natural history and predictors of early glucose abnormalities, determine the role of race during the second wave of glycemic progression, and to access the time dependency of reversibility of prediabetes. The study tests 4 hypotheses: 1) Among offspring of parents with type 2 diabetes, early progression from normal to impaired glucose regulation (within 5 yr) occurs in the highest-risk subjects independently of race, whereas late progression (5-10 yr) displays racial disparities, and is predicted by physiological, biochemical and behavioral markers; 2) Early microvascular complications, peripheral vascular disease (PVD), and endothelial dysfunction manifest during transition from normal to impaired glucose regulation, display racial disparities, and are predicted by glycemic and nonglycemic factors; 3) The "metabolically healthy" insulin-sensitive obese (ISO) phenotype displays racial disparities in its association with cardiometabolic risk factors and incident dysglycemia among African-Americans and Caucasians offspring of parents with type 2 diabetes; and 4) Duration of the prediabetic state is a major determinant of, and is inversely related to, the efficacy of lifestyle intervention to induce regression of the prediabetic phenotype and restoration of normal glucose regulation. Participants with prediabetes and others who develop prediabetes during PROP-ABC will receive Intensive Lifestyle intervention (ILI).
We define duration of prediabetes as the interval from date of confirmed prediabetes to the date of initiation of ILI, stratified to 3 prediabetes intervals: a) \<1 yr, b) 1 to \<3 yr, c) 3-6 yr. The primary outcome measure is restoration of normal glucose regulation (fasting plasma glucose \<100 mg/dl and 2-hour post-load plasma glucose \< 140 mg/dl). Secondary endpoints include normalization of either fasting plasma glucose or 2-hour post-load plasma glucose , occurrence of diabetes, insulin sensitivity and secretion. Data will be analyzed according to the "intention to treat" principle. Based on power calculations, a sample size of 150 subjects (50/prediabetes interval) would allow detection of medium to large effect off ILI with \~85% power. Kaplan-Meier survival curves will be generated for the 3 prediabetes intervals, and log-rank test will be used to analyze the time to occurrence of primary outcome. The prospective PROP-ABC, designed to identify new cases of prediabetes as they occur, is uniquely placed to test the time dependency of reversibility of incident prediabetes.
999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.
This study's enrollment of 223 is above the median of 65 across 844 interventional studies indexed under Prediabetic State.
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Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.
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Exclusion Criteria:
ILI consists of weight loss ( \> 10%); caloric reduction; physical activity (180 min/week); monthly visits for group counseling for 6 months, followed by quarterly visits; and meal replacements.
Behavioral: Intensive Lifestyle Intervention (ILI)
ILI consists of weight loss ( \> 10%); caloric reduction; physical activity (180 min/week); monthly visits for group counseling for 6 months, followed by quarterly visits; and meal replacements.
The primary outcome measure is restoration of normal glucose regulation
The primary outcome measure is restoration of normal glucose regulation (FPG \<100 mg/dl and 2hrPG \< 140 mg/dl).
Time frame: Up to 60 months
Glucose normalization
Secondary endpoints include normalization of either fasting plasma glucose or 2-hr OGTT plasma glucose levels, occurrence of diabetes, insulin sensitivity and secretion.
Time frame: Up to 60 months
Incident prediabetes in observational cohort
Incident prediabetes, microvascular complications, endothelial function, ankle-brachial index, body composition, adiposity measures, FPG, 2hPG , A1c, adipo- and inflammatory cytokines (hsCRP, TNF-a, IL-1a, IL-6, resistin, leptin and adiponectin), metabolic syndrome and individual components (waist, BP, triglycerides, HDL cholesterol, FPG), metabolically healthy and unhealthy obese phenotypes, transaminases (surrogate for liver fat), diet (FHQ score) physical activity (MAQ and NHANES scores) and smoking history.
Time frame: Up to 60 months
Plan to share: No — Group data will be published after completion of study and analysis of results. Individual participant-level information will not be shared.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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