Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) Study: design of lifestyle intervention

Samuel Dagogo-Jack, Amy A Brewer, Ibiye Owei, Lindsey French, Nkiru Umekwe, Renate Rosenthal, Jim Wan, Samuel Dagogo-Jack, Amy A Brewer, Ibiye Owei, Lindsey French, Nkiru Umekwe, Renate Rosenthal, Jim Wan

Abstract

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.

Keywords: dietary intervention; exercise; impaired glucose tolerance; research design.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Schematic showing design of the Pathobiology of Prediabetes in a Biracial Cohort (POP-ABC) Study and the Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) Study. IFG, impaired fasting glucose; IGT, impaired glucose tolerance; ILI, intensive lifestyle intervention; NFG, normal fasting glucose; NGT, normal glucose tolerance; OGTT, oral glucose tolerance test; T2DM, type 2 diabetes mellitus.
Figure 2
Figure 2
(A) Mean change in weight in relation to year 1 face-to-face contact frequency among 158 intensive lifestyle intervention participants. (B) Relationship between duration of meal replacement and 4-month change in body weight among participants who took meal replacement for at least 16 weeks. Change in weight was significantly correlated with face-to-face contact frequency (r=0.98, p

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