In the DiRECT study by Lean:
Population
Design
Intervention
Control
Outcome
Meaning of DiRECT
BR 355, Lean Lancet 2018:391:541-51
In the DiRECT study by Lean:
Population
- adults, NIDDM < 6 yrs w BMI 27-45, not on insulin
- n = 306 from 49 practices.
Design: Open label cluster RCT at 49 1' care practices in Scotland & England (statistician blinded)
Intervention
1) Withdraw anti-diabetic and BP drugs
2) Total diet replacement (~ 850 cal/d) with liquid formula x 3-5 mos then stepped food reintroduction (2-8 wks) & structured support for LTM weight loss maintenance
Control - best-practice care by guidelines
Outcome
Co-primary: 1) Wt loss > 15 kg,
2) Remission of DM (HbA1c < 6.5% after at least 2 mos off all diabetic meds).
DiRECT = Diabetes Remission Clinical Trial
Mn: JK leaning on 'DiRECT' - 'I want to push this'
What were the results In the DiRECT study by Lean:
1) Mean change in body weight
a) Rate of losing > 15 kg
2) Quality of life
3) Diabetes remission
4) Primary Predictor of remission
BR 355, Lean Lancet 2018:391:541-51
In the DiRECT study by Lean:
1) Mean dec in weight: 10.0 vs 1.0 Kg - delta 8.8 Kg (P<0.0001)
a) Loss of > 15 kg in 24% v 0%; P<0.0001
2) QOL (EuroQol VAS) improved by 7.2 points vs dec by 2.9 points. (delta 6.4 points; p=0.0012)
3) DM remission 46% vs 4%, OR 19.7; P<0.0001
4) Primary predictor of remission was weight loss:
- none in those who gained weight.
- 86% in those who lost 15kg or more
What were the results In the DiRECT study by Lean in comparison to LookAHEAD ? Why ?
BR 355, Lean Lancet 2018:391:541-51
Overall Direct had a 46% remission rate for NIDDM vs 11.5% (both at 1 yr) in Lookahead (& 2% on ADA diet)
- due to differences in dosing strength (1,200-1,800 cal/d in Lookahead vs 850 cal/d in Direct).
- used a low energy liquid replacement diet.
