RCT Wt loss DM DiRECT Flashcards Preview

LMBR KA11 Lean Lancet 2018 DiRECT > RCT Wt loss DM DiRECT > Flashcards

Flashcards in RCT Wt loss DM DiRECT Deck (3)
Loading flashcards...
1

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'

2

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

3

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.