Physical activity, inactivity and sleep during the Diabetes Remission Clinical Trial (<scp>DiRECT</scp>)

Cassidy, Sophie; Trenell, Michael I.; Stefanetti, Renae J.; Charman, Sarah J; Barnes, Alison C.; Brosnahan, Naomi; McCombie, Louise; Thom, George; Peters, Carl; Zhyzhneuskaya, Sviatlana; Leslie, W. S.; Catt, Christopher; Catt, Michael; McConnachie, Alex; Sattar, Naveed; Sniehotta, Falko F.; Lean, Michael E. J.; Taylor, Roy

doi:10.1111/dme.15010

Cited by 14 publications

(9 citation statements)

References 33 publications

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“…Both studies employed total diet replacement, with targets of approximately 800–850 kcal/day, and importantly, employed an active protocol-driven approach to medication removal. After 6 months, the DiRECT study re-introduced food [ 5 ] and provided advice to increase physical activity during the maintenance period [ 26 ]. Several other studies have observed similarly profound effects on HbA 1c with dietary replacement and intensive weight loss over a shorter time period than the DiRECT and Look AHEAD Studies [ 27 – 30 ].…”

Section: Discussionmentioning

confidence: 99%

Impact of remission from type 2 diabetes on long-term health outcomes: findings from the Look AHEAD study

Gregg,

Chen,

Bancks

et al. 2024

Diabetologia

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Aims/hypothesis We examined the association of attainment of diabetes remission in the context of a 12 year intensive lifestyle intervention with subsequent incidence of chronic kidney disease (CKD) and CVD. Methods The Look AHEAD study was a multi-centre RCT comparing the effect of a 12 year intensive lifestyle intervention with that of diabetes support and education on CVD and other long-term health conditions. We compared the incidence of CVD and CKD among 4402 and 4132 participants, respectively, based on achievement and duration of diabetes remission. Participants were 58% female, and had a mean age of 59 years, a duration of diabetes of 6 year and BMI of 35.8 kg/m2. We applied an epidemiological definition of remission: taking no diabetes medications and having HbA1c <48 mmol/mol (6.5%) at a single point in time. We defined high-risk or very high-risk CKD based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria, and CVD incidence as any occurrence of non-fatal acute myocardial infarction, stroke, admission for angina or CVD death. Results Participants with evidence of any remission during follow-up had a 33% lower rate of CKD (HR 0.67; 95% CI 0.52, 0.87) and a 40% lower rate of the composite CVD measure (HR 0.60; 95% CI 0.47, 0.79) in multivariate analyses adjusting for HbA1c, BP, lipid levels, CVD history, diabetes duration and intervention arm, compared with participants without remission. The magnitude of risk reduction was greatest for participants with evidence of longer-term remission. Conclusions/interpretation Participants with type 2 diabetes with evidence of remission had a substantially lower incidence of CKD and CVD, respectively, compared with participants who did not achieve remission. This association may be affected by post-baseline improvements in weight, fitness, HbA1c and LDL-cholesterol. Trial registration ClinicalTrials.gov NCT00017953 Data availability https://repository.niddk.nih.gov/studies/look-ahead/ Graphical Abstract

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Section: Discussionmentioning

confidence: 99%

Impact of remission from type 2 diabetes on long-term health outcomes: findings from the Look AHEAD study

Gregg,

Chen,

Bancks

et al. 2024

Diabetologia

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“…The predicted reduction in the resting energy rate in both trials is in accord with expectations and with other controlled weight loss studies that saw a 5.6–14.6% reduction in resting energy rate with similar weight loss ( 23 – 25 ). Lighter people must burn fewer calories unless more active and accelerometer data from DiRECT showed minimal change in activity ( 26 ). Notably, the improvement in cardiorespiratory fitness appeared to be rapid in DIADEM-I.…”

Section: Discussionmentioning

confidence: 99%

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

Sattar,

Taheri,

Astling

et al. 2023

Diabetes Care

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OBJECTIVE To determine the extent to which changes in plasma proteins, previously predictive of cardiometabolic outcomes, predict changes in two diabetes remission trials. RESEARCH DESIGN AND METHODS We applied SomaSignal predictive tests (each derived from ∼5,000 plasma protein measurements using aptamer-based proteomics assay) to baseline and 1-year samples of trial intervention (Diabetes Remission Clinical Trial [DiRECT], n = 118, and Diabetes Intervention Accentuating Diet and Enhancing Metabolism [DIADEM-I], n = 66) and control (DiRECT, n = 144, DIADEM-I, n = 76) group participants. RESULTS Mean (SD) weight loss in DiRECT (U.K.) and DIADEM-I (Qatar) was 10.2 (7.4) kg and 12.1 (9.5) kg, respectively, vs. 1.0 (3.7) kg and 4.0 (5.4) kg in control groups. Cardiometabolic SomaSignal test results showed significant improvement (Bonferroni-adjusted P < 0.05) in DiRECT and DIADEM-I (expressed as relative difference, intervention minus control) as follows, respectively: 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%), and cardiorespiratory fitness (9.5%, 10.3%). Cardiovascular risk (measured with SomaSignal tests) also improved in intervention groups relative to control, but this was significant only in DiRECT (DiRECT, −44.2%, and DIADEM-I, −9.2%). However, weight loss >10 kg predicted significant reductions in cardiovascular risk, −19.1% (95% CI −33.4 to −4.91) in DiRECT and −33.4% (95% CI −57.3, −9.6) in DIADEM-I. DIADEM-I also demonstrated rapid emergence of metabolic improvements at 3 months. CONCLUSIONS 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.

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“…Weight reduction in overweight and obese people with type 2 diabetes results in the reduction of vascular risks, increases self-esteem, quality of life and can lead to remission in the early stages of type 2 diabetes 51 52 53 54 55 56 . In the current clinical practice guidelines in this supplement, there is an extensive section on obesity and diabetes 57 .…”

Section: Therapymentioning

confidence: 99%

Therapy of Type 2 Diabetes

Landgraf,

Aberle,

Birkenfeld

et al. 2024

Exp Clin Endocrinol Diabetes

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Physical activity, inactivity and sleep during the Diabetes Remission Clinical Trial (DiRECT)

Cited by 14 publications

References 33 publications

Impact of remission from type 2 diabetes on long-term health outcomes: findings from the Look AHEAD study

Impact of remission from type 2 diabetes on long-term health outcomes: findings from the Look AHEAD study

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

Therapy of Type 2 Diabetes

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