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

August 15, 2018 updated by: Pavel Klein, Mid-Atlantic Epilepsy and Sleep Center, LLC

Evaluation of Efficacy and Safety of Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea.

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
9 months
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.
9 months
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.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mid-Atlantic Epilepsy and Sleep Center, LLC

Investigators

  • Principal Investigator: Pavel Klein, M.D., Mid-Atlantic Epilepsy and Sleep Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

July 19, 2013

First Submitted That Met QC Criteria

February 19, 2014

First Posted (Estimate)

February 24, 2014

Study Record Updates

Last Update Posted (Actual)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • maes 004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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