Recruiting
Phase 2

Ketogenic Diet

Sponsor:

Mid-Atlantic Epilepsy and Sleep Center, LLC

Code:

NCT02069197

Conditions

Obesity

Diabetes

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Ketogenic diet

Orlistat

Standardized diet

Study Details

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).

Conditions

Obesity

Diabetes

Obstructive Sleep Apnea

Study ID

NCT02069197

Start date

Jan, 2014

Status verified date

Aug, 2018

Completion date

Sep, 2020

Anticipated

Primary completion date

Aug, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Ketogenic diet, lifestyle counseling

ketogenic diet consisted of 3:1\[fat\]:\[protein+carbohydrate\] weight ratio with 1600kcal restriction.

active comparator: Orlistat, Lifestyle counseling

Orlistat 120 mg TID, standardized diet and lifestyle-modification counseling based on the LEARN (Life, Exercise, Attitudes, Relationships,and Nutrition) program with recommended caloric goal of 1600 kcal/day.

active comparator: Standartized diet, Lifestyle counseling

Standardized diet and lifestyle-modification counseling based on the LEARN (Lifestyle, Exercise, Attitudes, Relationship, Nutrition) program with recommended caloric goal of 1600kcal/day.

Interventions

Ketogenic diet

ketogenic diet will consist of 3:1\[fat\]:\[protein+carbohydrate\]weight ratio with 1600 kcal restriction. Diet will last 9 months.

Orlistat

Orlistat 120 mg TID for 9 months; life style intervention with recommended caloric goal of 1600 kcal/day.

Standardized diet

Standardized diet treatment for 9 months with recommended caloric goal of 1600kcal/day.

Primary outcome measure

  • Change of body mass index from baseline in 9 months period [ Time Frame: 9 months ]

Central Contacts and Locations

Central contacts

Ivana Tyrlikova, MD

301-530-9744tyrlikovai@epilepsydc.com

Arcady Barber, MSCN

301-530-9744barbera@epilepsydc.com

Locations

Mid-Atlantic Epilepsy and Sleep Center, LLC

Recruiting

Bethesda, Maryland, United States, 20817

Contacts

Ivana Tyrlikova, MD

301-530-9744tyrlikovai@epilepsydc.com

Arcady Barber, MSCN

301-530-9744barbera@epilepsydc.com

More Information

Sponsor

Mid-Atlantic Epilepsy and Sleep Center, LLC

Last update posted

Aug 17, 2018

Last verified

Aug, 2018

Keywords

  • ketogenic diet
  • obesity
  • diabetes
  • obstructive sleep apnea

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mid-Atlantic Epilepsy and Sleep Center, LLC on 2018-08-17.