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

Obesity Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02069197
• Other study ID #: maes 004
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2014
• Est. completion date: September 2020

Study information

• Verified date: August 2018
• Source: Mid-Atlantic Epilepsy and Sleep Center, LLC
• Contact: Ivana Tyrlikova, MD
• Phone: 301-530-9744
• Email: tyrlikovai[@]epilepsydc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

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

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

Locations

Country	Name	City	State
United States	Mid-Atlantic Epilepsy and Sleep Center, LLC	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Mid-Atlantic Epilepsy and Sleep Center, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of body mass index from baseline in 9 months period	The change of weight and the BMI(body mass index) will be calculated.	9 months
Secondary	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	9 months
Secondary	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.	9 months
Secondary	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.	9 months