Type 2 & other diabetes

Prediction of Cardiometabolic Health Through Changes in Plasma Proteins With Intentional Weight Loss in the DiRECT (DiRECT) and DIADEM-I Randomized Clinical Trials of Type 2 Diabetes Remission

Diabetes CarePublished Secondary analysis of the DiRECT and DIADEM-I randomised trials

Authors' conclusion

Intentional weight loss in recent-onset type 2 diabetes rapidly induces changes in protein-based risk models consistent with widespread cardiometabolic improvements, including cardiorespiratory fitness. Protein changes with greater (>10 kg) weight loss also predicted lower cardiovascular risk, providing a positive outlook for relevant ongoing trials.

Study context

Population
Participants in two T2D remission trials, DiRECT (UK) and DIADEM-I (Qatar), with baseline and 1-year samples
Participants
118 / 144 / 66 / 76
Comparison
Intensive weight-loss intervention vs control, in DiRECT and DIADEM-I
  • DiRECT interventionn = 118
  • DiRECT controln = 144reference
  • DIADEM-I interventionn = 66
  • DIADEM-I controln = 76reference
Primary endpoint
Changes in SomaSignal protein-based predictive test results for cardiometabolic outcomes:
  • Relative difference
  • Intervention minus control
Follow-up
1 year
Methodological detailsproteomics (aptamer-based), SomaSignal predictive tests
  • Proteomics (aptamer-based)
  • SomaSignal predictive tests

Primary result

As reported in the abstract

SomaSignal cardiometabolic tests, relative difference intervention minus control (DiRECT, DIADEM-I)
Liver fat
−26.4%, −37.3%
Glucose tolerance
−36.6%, −37.4%
Body fat percentage
−8.6%, −8.7%
Resting energy rate
−8.0%, −5.1%
Visceral fat
−34.3%, −26.1%
Cardiorespiratory fitness
9.5%, 10.3%

Further findings

Weight loss · 1 year

Cardiovascular risk (SomaSignal), relative difference intervention minus control

DiRECT (significant)
−44.2%
DIADEM-I (not significant)
−9.2%

Cardiovascular risk (SomaSignal) with weight loss >10 kg

DiRECT
−19.1% (95% CI −33.4 to −4.91)
DIADEM-I
−33.4% (95% CI −57.3, −9.6)

Metabolic improvements at 3 months (DIADEM-I)

Rapid emergence of metabolic improvements in DIADEM-I

Original publication

Prediction of Cardiometabolic Health Through Changes in Plasma Proteins With Intentional Weight Loss in the DiRECT and DIADEM-I Randomized Clinical Trials of Type 2 Diabetes Remission. Diabetes Care. Published 26 September 2023. doi:10.2337/dc23-0602

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