Randomised controlled trialindependent cross-checkabstract only checked★ key study I-FAST-12 in-depth review
DiRECT: weight loss to put type 2 diabetes into remission
Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial.
Overview
Lean ME et al.. Lancet 2018 · PMID 29221645 · DOI 10.1016/S0140-6736(17)33102-1
46% of people in the programme were free of diabetes and medication after one year.
Does the study support the specific claim? Partly · Methodological quality: high
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Can intensive weight management in primary care achieve T2D remission?
- How was the study done?
Open-label cluster-randomised trial (DiRECT)
- How many people, animals or samples were studied?
306 (149 per group ITT); 49 practices; Age 20-65, T2D <6 years, BMI 27-45, not on insulin
- What was actually found?
Remission 46% vs 4%.
- How large was the observed effect?
OR 19.7
- What do the results mean in everyday life?
Losing 10-15 kg can reverse early type 2 diabetes.
- What are the study's limitations?
Open-label; Selected population; Formula diet
- What does it say about Elawady's specific claim?
Supports C-DIAB-03 (with conditions); limited relevance to C-INS-10 (insulin users excluded).
- Do the results apply to Germany and Europe?
UK; directly relevant.
- What can explicitly not be concluded from this study?
Effect of the Tayebat diet; effect in type 1 or insulin-treated diabetes.
Scientific in-depth review
1. Full reference
- Authors
- Lean ME et al.
- Journal
- Lancet
- Year
- 2018
- Identifier
- PMID 29221645 DOI 10.1016/S0140-6736(17)33102-1
- Verification
- verified – PubMed efetch 2026-10-25 (this agent)
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
Funded by Diabetes UK.
2. Research question
Can intensive weight management in primary care achieve T2D remission?
3. Study design and population
- Study design
- Randomised controlled trial – Open-label cluster-randomised trial (DiRECT)
- Population
Age 20-65, T2D <6 years, BMI 27-45, not on insulin
- Country
UK (Scotland, Tyneside)
- Period
2014-2017; 12 months
- Sample size
306 (149 per group ITT); 49 practices
- Inclusion and exclusion criteria
As described in the abstract; details not available in abstract.
4. Methods and endpoints
- Exposure / intervention
Drug withdrawal, total diet replacement 825-853 kcal/day 3-5 months, food reintroduction, maintenance support
- Comparator
Best-practice guideline care
- Endpoints
Weight loss >=15 kg; remission (HbA1c <6.5% off drugs >=2 months)
- Statistical methods
Hierarchical ITT
5. Actual results
- Results
Weight loss >=15 kg 24% vs 0%; remission 46% vs 4% (OR 19.7, 7.8-49.8). Remission by weight loss: 0% (gain), 7% (0-5 kg), 34% (5-10), 57% (10-15), 86% (>=15). Mean weight -10.0 vs -1.0 kg. 9 vs 2 SAEs.
- Absolute risks
Remission 46% vs 4%.
- Authors' conclusion
Almost half achieved remission off antidiabetic drugs at 12 months.
6. Strengths
- Randomised
- Primary care setting
- Clear definition
7. Weaknesses
- Open-label
- Selected population
- Formula diet
8. Risk of bias
- Orienting tool
- RoB 2
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- some concerns
- Rationale
Open-label, objective HbA1c outcome.
9. Assessment of the statistical interpretation
Large effect, dose-response with weight loss.
10. Relevance to the specific claim
Supports C-DIAB-03 (with conditions); limited relevance to C-INS-10 (insulin users excluded).
11. Independent contrary findings
I-FAST-14 (durability).
12. Transferability to Germany and Europe
UK; directly relevant.
13. Overall methodological judgement
Strong evidence that substantial weight loss can induce remission of early T2D.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | some concerns |
| Precision of results | moderate |
| Directness | direct |
| Reproducibility | partly replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | moderate |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
None beyond those stated.
15. Linked fact checks
- People with diabetes can stop insulin and diabetes medication by following the Tayebat system ('zero medicine'), as shown by followers who stopped insulin and are 'perfectly fine'. – Studies supporting the claim
- Diabetes can be cured by following the Tayebat system without medication, illustrated by a patient who stopped insulin after 30 years of insulin use. – Studies supporting the claim
- Insulin is the single and only cause of obesity (local or generalised) because it is the only hormone that builds fat and blocks fat breakdown (lipolysis). – Studies contradicting or limiting the claim