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
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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