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 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obesity Diabetes Obstructive Sleep Apnea||Other: Ketogenic diet Drug: Orlistat Other: Standardized diet||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|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 :||August 2020|
|Estimated Study Completion Date :||September 2020|
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.
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.
- 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.
- 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
- 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.
- 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.
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
|Contact: Ivana Tyrlikova, MDemail@example.com|
|Contact: Arcady Barber, MSCNfirstname.lastname@example.org|
|United States, Maryland|
|Mid-Atlantic Epilepsy and Sleep Center, LLC||Recruiting|
|Bethesda, Maryland, United States, 20817|
|Contact: Ivana Tyrlikova, MD 301-530-9744 email@example.com|
|Contact: Arcady Barber, MSCN 301-530-9744 firstname.lastname@example.org|
|Principal Investigator:||Pavel Klein, M.D.||Mid-Atlantic Epilepsy and Sleep center|