Bethesda, Maryland 20817


Purpose:

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).


Study summary:

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.


Criteria:

Inclusion Criteria: - age 18-70 - ability and willingness to signed informed consent form - BMI more than 30kg/m2, with type 2 DM and/or OSA - For diabetic participants, stable hypoglycemic medications for at least 2 months - For participants with OSA, previously documented polysomnogram with apnea/hypopnea index (AHI)>15/h. Exclusion Criteria: - BMI change of +/- 3.0 kg/m2 of baseline BMI within past 12 months. - History of bariatric surgery ≤ 3 years prior to enrollment. - Any systemic illness or unstable medical condition that might pose additional risk, including: cardiac, unstable metabolic or endocrine disturbances, renal or liver disease, past history of renal calculi, hyperuricemia, hypercalcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, and active systemic cancer. - History of uncontrolled hyperlipidemia - For participants with DM, change in the dose or type of hypoglycemic treatment within 2 months prior to enrollment. - Psychosis within six months of enrollment, evidenced by treatment with anti-psychotic medications with recent medication initiation or dose increase. - Active drug or alcohol dependence or any other factors that, in the opinion of the site investigators would interfere with adherence to study requirements; - History of hyperthyroidism - History of glaucoma - History of cerebrovascular disease or unstable heart disease within 6 months of enrollment - Pregnancy - Use of any investigational drugs within 3 months of enrollment. - Inability or unwillingness of subject to give written informed consent.


NCT ID:

NCT02069197


Primary Contact:

Principal Investigator
Pavel Klein, M.D.
Mid-Atlantic Epilepsy and Sleep center

Ivana Tyrlikova, MD
Phone: 301-530-9744
Email: tyrlikovai@epilepsydc.com


Backup Contact:

Email: barbera@epilepsydc.com
Arcady Barber, MSCN
Phone: 301-530-9744


Location Contact:

Bethesda, Maryland 20817
United States

Ivana Tyrlikova, MD
Phone: 301-530-9744
Email: tyrlikovai@epilepsydc.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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