search
Back to results

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

Primary Purpose

Obesity, Diabetes, Obstructive Sleep Apnea

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ketogenic diet
Orlistat
Standardized diet
Sponsored by
Mid-Atlantic Epilepsy and Sleep Center, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring ketogenic diet, obesity, diabetes, obstructive sleep apnea

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mid-Atlantic Epilepsy and Sleep Center, LLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Ketogenic diet, lifestyle counseling

Orlistat, Lifestyle counseling

Standartized diet, Lifestyle counseling

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

Change of body mass index from baseline in 9 months period
The change of weight and the BMI(body mass index) will be calculated.

Secondary Outcome Measures

Change from baseline in glucose blood level in patients with diabetes mellitus in 9 months.
HbA1C, fasting serum glucose insulin and leptin levels and fasting lipid levels
Change of apnea/hypopnea index in patients with obstructive sleep apnea in patients with obesity
For participants with OSA, secondary outcome will include polysomnogram-derived apnea/hypopnea index. Level of alertness will be evaluated with Epworth Sleepiness Scale.
To evaluate safety of ketogenic diet as a treatment of obesity.
Evaluate in serum levels of beta-hydroxybutyrate, glucose, electrolytes, renal and liver functions, uric acid, HbA1C, serum lipid profile, insulin and leptin levels, CRP.

Full Information

First Posted
July 19, 2013
Last Updated
August 15, 2018
Sponsor
Mid-Atlantic Epilepsy and Sleep Center, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT02069197
Brief Title
Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea
Acronym
KGDobesity
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mid-Atlantic Epilepsy and Sleep Center, LLC

4. Oversight

Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diabetes, Obstructive Sleep Apnea
Keywords
ketogenic diet, obesity, diabetes, obstructive sleep apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketogenic diet, lifestyle counseling
Arm Type
Active Comparator
Arm Description
ketogenic diet consisted of 3:1[fat]:[protein+carbohydrate] weight ratio with 1600kcal restriction.
Arm Title
Orlistat, Lifestyle counseling
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standartized diet, Lifestyle counseling
Arm Type
Active Comparator
Arm Description
Standardized diet and lifestyle-modification counseling based on the LEARN (Lifestyle, Exercise, Attitudes, Relationship, Nutrition) program with recommended caloric goal of 1600kcal/day.
Intervention Type
Other
Intervention Name(s)
Ketogenic diet
Other Intervention Name(s)
high fat, low protein, low carbohydrate diet
Intervention Description
ketogenic diet will consist of 3:1[fat]:[protein+carbohydrate]weight ratio with 1600 kcal restriction. Diet will last 9 months.
Intervention Type
Drug
Intervention Name(s)
Orlistat
Other Intervention Name(s)
tetrahydrolipstatin
Intervention Description
Orlistat 120 mg TID for 9 months; life style intervention with recommended caloric goal of 1600 kcal/day.
Intervention Type
Other
Intervention Name(s)
Standardized diet
Intervention Description
Standardized diet treatment for 9 months with recommended caloric goal of 1600kcal/day.
Primary Outcome Measure Information:
Title
Change of body mass index from baseline in 9 months period
Description
The change of weight and the BMI(body mass index) will be calculated.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Change from baseline in glucose blood level in patients with diabetes mellitus in 9 months.
Description
HbA1C, fasting serum glucose insulin and leptin levels and fasting lipid levels
Time Frame
9 months
Title
Change of apnea/hypopnea index in patients with obstructive sleep apnea in patients with obesity
Description
For participants with OSA, secondary outcome will include polysomnogram-derived apnea/hypopnea index. Level of alertness will be evaluated with Epworth Sleepiness Scale.
Time Frame
9 months
Title
To evaluate safety of ketogenic diet as a treatment of obesity.
Description
Evaluate in serum levels of beta-hydroxybutyrate, glucose, electrolytes, renal and liver functions, uric acid, HbA1C, serum lipid profile, insulin and leptin levels, CRP.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ivana Tyrlikova, MD
Phone
301-530-9744
Email
tyrlikovai@epilepsydc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Arcady Barber, MSCN
Phone
301-530-9744
Email
barbera@epilepsydc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavel Klein, M.D.
Organizational Affiliation
Mid-Atlantic Epilepsy and Sleep center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mid-Atlantic Epilepsy and Sleep Center, LLC
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivana Tyrlikova, MD
Phone
301-530-9744
Email
tyrlikovai@epilepsydc.com
First Name & Middle Initial & Last Name & Degree
Arcady Barber, MSCN
Phone
301-530-9744
Email
barbera@epilepsydc.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs