Introduction Intensive lifestyle intervention (ILI) prevents progression from prediabetes to type 2 diabetes (T2D) but reversal of prediabetes is less well studied.
Research design and methods The overall objectives of the Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) Study (ClinicalTrials.gov ID: NCT02027571) are to determine the natural history and reversibility of prediabetes. The study tests specific hypotheses on the patterns of progression to prediabetes among normoglycemic African-American (AA) and European-American (EA) offspring of parents with T2D; emergence of microvascular and macrovascular complications during transition from normal to impaired glucose regulation; significance of the ‘metabolically healthy’ obese phenotype; and effect of duration of the prediabetic state on its reversibility with lifestyle intervention. Participants who developed incident prediabetes were offered ILI and evaluated quarterly for 5 years. The primary outcome was restoration of normal glucose regulation (fasting plasma glucose <100 mg/dL and two-hour plasma glucose (2hrPG)<140 mg/dL).
Results Of the 223 subjects enrolled in the PROP-ABC Study, 158 participants with incident prediabetes started ILI. The mean age was 53.3±9.28 years; body mass index 30.6±6.70 kg/m2; 70% were female, 52.4% AA and 47.6% EA. The ILI program used goal setting, weight-based calorie restriction, physical activity (180 min/week), self-monitoring, and meal replacement. Monthly face-to-face (F2F) counseling sessions during the initial 6 months, and quarterly visits thereafter, were supplemented with electronic and postal contacts. Attendance at F2F sessions was highly correlated with weight loss (r=0.98, p<0.0001). Meal replacement induced ~5 kg weight loss within 3 months in participants with recrudescent weight pattern. Self-reported exercise minutes correlated with pedometer step counts (r=0.47, p<0.0001).
Conclusion The PROP-ABC Study has demonstrated the feasibility of executing an ILI program designed to test reversibility of incident prediabetes in a biracial cohort.
- impaired glucose tolerance
- research design
- dietary intervention
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Contributors All authors materially participated in the research and article preparation and gave final approval for the version submitted. SD-J conceived of and designed the study, analyzed data, drafted manuscript; AAB, IO, LF, NU, RR collected data, reviewed and revised manuscript; JW performed statistical analysis, and reviewed and revised the manuscript.
Funding This work was supported by the National Institutes of Health grant number R01 DK067269.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The PROP-ABC Study protocol (ClinicalTrials.gov ID: NCT02027571) was approved by the University of Tennessee Health Science Center Institutional Review Board (Approval number 12–01970-FB).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article. Deidentified data are available for sharing upon reasonable request.
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