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Grand Rounds

Results of the DiRECT Trial: Can Weight Loss in a Primary Care Setting Achieve Remission of Type 2 Diabetes?

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BACKGROUND AND PURPOSE:

  • Type 2 diabetes is related to excess weight gain and fat deposition in the liver and pancreas
  • There is evidence that weight loss can return individuals from type 2 diabetes to normal insulin resistance status and glucose control
  • Data is lacking as to whether such interventions are practical in a routine primary care setting
  • Lean et al. (The Lancet, 2017) sought to determine whether intensive weight management within a routine primary care setting can achieve remission of type 2 diabetes

METHODS:

  • Open-label, randomized trial
  • DiRECT: Diabetes Remission Clinical Trial
  • Patients: 20-65 year olds diagnosed with type 2 diabetes within the last 6 years, BMI of 27-45 kg/m2, and not receiving insulin
  • Patients were recruited from 49 primary care practices
  • Practices were randomly assigned to
    • Weight management program (intervention group)
    • Best-practice care based on guidelines (control group)
  • Intervention
    • Withdrawal of antidiabetic and antihypertensive drugs
    • Total diet replacement (825–853 kcal/day formula diet for 3–5 months)
      • 59% carbohydrate, 13% fat, 26% protein, 2% fiber
    • Structured food reintroduction (2–8 weeks)
      • 50% carbohydrate, 35% total fat, and 15% protein
    • Structured support for long-term weight loss maintenance
      • Monthly visits
    • Regular, not additional, physical activity was encouraged during total diet replacement with activity strategies introduced to help reach and maintain sustainable maximum of up to 15,000 steps/day measured with wearables
  • Data was stratified for study site and practice size
  • All outcome data were collected at baseline and at 12 months
  • Majority of study was not blinded except to study statisticians
  • Primary outcomes
    • Weight loss of ≥ 15 kg or more
    • Remission of diabetes, defined as HbA1c < 6.5% (<48 mmol/mol) after at least 2 months off all antidiabetic medications from baseline to month 12

RESULTS:

  • 306 individuals were recruited
    • 149 participants per group comprised the intention-to-treat population
  • 24% of intervention group lost ≥ 15 kg compared to 0% in the control group (p<0.0001)
  • Diabetes remission was achieved in 46% participants in the intervention group and six (4%) of the control group
    • odds ratio (OR) 19.7, 95% CI 7.8–49.8; p<0.0001
  • Remission varied with weight loss:
    • No remission in 76 participants who gained weight
    • 7% of 89 participants who maintained 0–5 kg weight loss
    • 34% of 56 participants with 5–10 kg loss
    • 57% of 28 participants with 10–15 kg loss
    • 86% of 36 participants who lost 15 kg or more
  • At 12 months, 74% in the intervention group were taking no antidiabetic medications (mean HbA1c 64% [46.8 mmol/mol]) compared with 18% of the control group (mean HbA1c 7.2% [54.6 mmol/mol]; p=0·0032)
  • Mean bodyweight fell by 10.0 kg (SD 8.0) in the intervention group and 1.0 kg (3.7) in the control group
    • adjusted difference of −8.8 kg, 95% CI −10.3 to −7.3; p<0·0001
  • Quality of life, as measured by the EuroQol 5 Dimensions visual analogue scale, improved by 7.2 points in the intervention group, and decreased by 2.9 points in the control group
    • Adjusted difference of 6.4 points, 95% CI 2.5–10.3; p=0.0012
  • Nine serious adverse events were reported: 4% in the intervention group and 1% in the control group
  • In the same participant, two serious adverse events (biliary colic and abdominal pain) were potentially related to the intervention

CONCLUSION:

  • Authors acknowledge that bariatric surgery has “dominated discussions of type 2 diabetes remission as the most effective way of producing major weight loss”
    • May be associated with risk of long-term problems and may not be practical due to the increasing number of people with type 2 diabetes
  • Weight loss also led to drops in blood pressure such that intervention group participants were able to stop their blood pressure medications for the 12 months of this study
  • Remission may not work in individuals who have been diabetic for > 6 years
  • Almost half of participants achieved remission to a non-diabetic state and off antidiabetic drugs, making remission a practical target for primary care
  • Follow-up will continue to at least 4 years out

Learn More – Primary Sources:

Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial

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Related ObG Topics:

Does Gestational Hypertension Increase Risk of Type 2 Diabetes in Adult Offspring?
What is the Effect of High-Intensity Training on Diabetes and Cardiovascular Disease in Menopause?
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