NCT02069197

Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea

Evaluation of Efficacy and Safety of Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Mid-Atlantic Epilepsy and Sleep Center, LLC · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy and safety of ketogenic diet (KD) treatment of (i) obesity, (ii) type 2 diabetes mellitus and (iii) obstructive sleep apnea (OSA) in patients with obesity and Type 2 DM and in patients with obesity and/or OSA. This will be a randomized, open-label three arm controlled study comparing weight loss in obese participants with type 2 diabetes and/or obstructive sleep apnea treated for 9 months with 3:1 \[fat\]:\[protein+carbohydrate\] ratio, 1600 kcal/day diet (Group A) with weight loss in participants treated with orlistat 120 mg TID and lifestyle intervention consisting of dietary advice, recommended caloric goal of 1600 kcal/day (Group B), and in participants treated with only lifestyle intervention consisting of dietary advice, recommended caloric goal of 1600 kcal/day (Group C).

Detailed description

The study sample will be randomized into three treatment arms, KD (Group A, n=50), Orlistat 120 mg TID (Group B, n=50) and dietary and lifestyle counseling (Group C, n=50) in a 1:1:1 ratio. Each arm will include 100% participants with obesity and co-morbid type 2 DM and 50% participants with co-morbid OSA. Randomization will be stratified for diabetic status.

Conditions

• Obesity
• Diabetes
• Obstructive Sleep Apnea

Interventions

Type	Name	Description
OTHER	Ketogenic diet	ketogenic diet will consist of 3:1\[fat\]:\[protein+carbohydrate\]weight ratio with 1600 kcal restriction. Diet will last 9 months.
DRUG	Orlistat	Orlistat 120 mg TID for 9 months; life style intervention with recommended caloric goal of 1600 kcal/day.
OTHER	Standardized diet	Standardized diet treatment for 9 months with recommended caloric goal of 1600kcal/day.

Timeline

• Start date: 2014-01-01
• Primary completion: 2020-08-01
• Completion: 2020-09-01
• First posted: 2014-02-24
• Last updated: 2018-08-17

Locations

1 site across 1 country: United States