We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea (KGDobesity)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02069197
Recruitment Status : Recruiting
First Posted : February 24, 2014
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Obesity Diabetes Obstructive Sleep Apnea Other: Ketogenic diet Drug: Orlistat Other: Standardized diet Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2014
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Orlistat
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Ketogenic diet, lifestyle counseling
ketogenic diet consisted of 3:1[fat]:[protein+carbohydrate] weight ratio with 1600kcal restriction.
Other: Ketogenic diet
ketogenic diet will consist of 3:1[fat]:[protein+carbohydrate]weight ratio with 1600 kcal restriction. Diet will last 9 months.
Other Name: high fat, low protein, low carbohydrate diet
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.
Drug: Orlistat
Orlistat 120 mg TID for 9 months; life style intervention with recommended caloric goal of 1600 kcal/day.
Other Name: tetrahydrolipstatin
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.
Other: Standardized diet
Standardized diet treatment for 9 months with recommended caloric goal of 1600kcal/day.


Outcome Measures

Primary Outcome Measures :
  1. Change of body mass index from baseline in 9 months period [ Time Frame: 9 months ]
    The change of weight and the BMI(body mass index) will be calculated.


Secondary Outcome Measures :
  1. Change from baseline in glucose blood level in patients with diabetes mellitus in 9 months. [ Time Frame: 9 months ]
    HbA1C, fasting serum glucose insulin and leptin levels and fasting lipid levels

  2. Change of apnea/hypopnea index in patients with obstructive sleep apnea in patients with obesity [ Time Frame: 9 months ]

    For participants with OSA, secondary outcome will include polysomnogram-derived apnea/hypopnea index.

    Level of alertness will be evaluated with Epworth Sleepiness Scale.


  3. To evaluate safety of ketogenic diet as a treatment of obesity. [ Time Frame: 9 months ]
    Evaluate in serum levels of beta-hydroxybutyrate, glucose, electrolytes, renal and liver functions, uric acid, HbA1C, serum lipid profile, insulin and leptin levels, CRP.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069197


Contacts
Contact: Ivana Tyrlikova, MD 301-530-9744 tyrlikovai@epilepsydc.com
Contact: Arcady Barber, MSCN 301-530-9744 barbera@epilepsydc.com

Locations
United States, Maryland
Mid-Atlantic Epilepsy and Sleep Center, LLC Recruiting
Bethesda, Maryland, United States, 20817
Contact: Ivana Tyrlikova, MD    301-530-9744    tyrlikovai@epilepsydc.com   
Contact: Arcady Barber, MSCN    301-530-9744    barbera@epilepsydc.com   
Sponsors and Collaborators
Mid-Atlantic Epilepsy and Sleep Center, LLC
Investigators
Principal Investigator: Pavel Klein, M.D. Mid-Atlantic Epilepsy and Sleep center
More Information

Responsible Party: Pavel Klein, MD, Mid-Atlantic Epilepsy and Sleep Center, LLC
ClinicalTrials.gov Identifier: NCT02069197     History of Changes
Other Study ID Numbers: maes 004
First Posted: February 24, 2014    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Pavel Klein, Mid-Atlantic Epilepsy and Sleep Center, LLC:
ketogenic diet
obesity
diabetes
obstructive sleep apnea

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Apnea
Diabetes Mellitus, Type 2
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Orlistat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents