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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
ketogenic diet will consist of 3:1\[fat\]:\[protein+carbohydrate\]weight ratio with 1600 kcal restriction. Diet will last 9 months.
Orlistat 120 mg TID for 9 months; life style intervention with recommended caloric goal of 1600 kcal/day.
Standardized diet treatment for 9 months with recommended caloric goal of 1600kcal/day.
Mid-Atlantic Epilepsy and Sleep Center, LLC
Bethesda, Maryland, United States
RECRUITINGChange of body mass index from baseline in 9 months period
The change of weight and the BMI(body mass index) will be calculated.
Time frame: 9 months
Change from baseline in glucose blood level in patients with diabetes mellitus in 9 months.
HbA1C, fasting serum glucose insulin and leptin levels and fasting lipid levels
Time frame: 9 months
Change of apnea/hypopnea index in patients with obstructive sleep apnea in patients with obesity
For participants with OSA, secondary outcome will include polysomnogram-derived apnea/hypopnea index. Level of alertness will be evaluated with Epworth Sleepiness Scale.
Time frame: 9 months
To evaluate safety of ketogenic diet as a treatment of obesity.
Evaluate in serum levels of beta-hydroxybutyrate, glucose, electrolytes, renal and liver functions, uric acid, HbA1C, serum lipid profile, insulin and leptin levels, CRP.
Time frame: 9 months
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