Clinical trial NCT02069197: Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea
Official title: Evaluation of Efficacy and Safety of Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Obesity
Diabetes
Obstructive Sleep Apnea
Keywords: ketogenic diet
obesity
diabetes
obstructive sleep apnea
Lead sponsor: Mid-Atlantic Epilepsy and Sleep Center, LLC
Sponsor class: OTHER
First posted: 2014-02-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Change of body mass index from baseline in 9 months period
timeFrame: 9 months
Secondary outcomes:
measure: Change from baseline in glucose blood level in patients with diabetes mellitus in 9 months.
timeFrame: 9 months
measure: Change of apnea/hypopnea index in patients with obstructive sleep apnea in patients with obesity
timeFrame: 9 months
measure: To evaluate safety of ketogenic diet as a treatment of obesity.
timeFrame: 9 months
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Mid-Atlantic Epilepsy and Sleep Center, LLC
state: Maryland
Study officials:
affiliation: Mid-Atlantic Epilepsy and Sleep center
name: Pavel Klein, M.D.
role: PRINCIPAL_INVESTIGATOR
References: