RCT Wt loss DM DiRECT Flashcards

(3 cards)

1
Q

In the DiRECT study by Lean:

Population

Design

Intervention

Control

Outcome

Meaning of DiRECT

BR 355, Lean Lancet 2018:391:541-51

A

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’

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2
Q

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

A

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

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3
Q

What were the results In the DiRECT study by Lean in comparison to LookAHEAD ? Why ?

BR 355, Lean Lancet 2018:391:541-51

A

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.
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