The effect of lifestyle intervention and metformin on preventing or delaying diabetes among women with and without gestational diabetes: the Diabetes Prevention Program outcomes study 10-year follow-up

Abstract

Context: Gestational diabetes (GDM) confers a high risk of type 2 diabetes. In the Diabetes Prevention Program (DPP), intensive lifestyle (ILS) and metformin prevented or delayed diabetes in women with a history of GDM.

Objective: The objective of the study was to evaluate the impact of ILS and metformin intervention over 10 years in women with and without a history of GDM in the DPP/Diabetes Prevention Program Outcomes Study.

Design: This was a randomized controlled clinical trial with an observational follow-up.

Setting: The study was conducted at 27 clinical centers.

Participants: Three hundred fifty women with a history of GDM and 1416 women with previous live births but no history of GDM participated in the study. The participants had an elevated body mass index and fasting glucose and impaired glucose tolerance at study entry.

Interventions: Interventions included placebo, ILS, or metformin.

Outcomes measure: Outcomes measure was diabetes mellitus.

Results: Over 10 years, women with a history of GDM assigned to placebo had a 48% higher risk of developing diabetes compared with women without a history of GDM. In women with a history of GDM, ILS and metformin reduced progression to diabetes compared with placebo by 35% and 40%, respectively. Among women without a history of GDM, ILS reduced the progression to diabetes by 30%, and metformin did not reduce the progression to diabetes.

Conclusions: Women with a history of GDM are at an increased risk of developing diabetes. In women with a history of GDM in the DPP/Diabetes Prevention Program Outcomes Study, both lifestyle and metformin were highly effective in reducing progression to diabetes during a 10-year follow-up period. Among women without a history of GDM, lifestyle but not metformin reduced progression to diabetes.

Trial registration: ClinicalTrials.gov NCT00004992 NCT00038727.

Figure 1.

Disposition of parous women with at least one live birth, categorized by history of GDM or no history of GDM, in DPP/DPPOS.

Figure 2.

Cumulative incidence of diabetes in women with a history of GDM (n = 350) (A) and parous women without a history of GDM (B) (n = 1416) during the 10-year study period.

Figure 3.

Cumulative incidence of diabetes in women with a history of GDM ( (A) n = 218) and parous women without a history of GDM (B) (n = 352) 25–44 years of age.

Figure 4.

Cumulative incidence of diabetes in women with a history of GDM (A) (n = 121) and parous women without a history of GDM (B) (n = 791) 45–59 years of age.

Figure 5.

Change in weight over time in women with a history of GDM (n = 350) (A) and parous women without a history of GDM (B) (n = 1416) by intention to treat.