Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea
Status:
Unknown status
Trial end date:
2020-09-01
Target enrollment:
Participant gender:
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).