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

Mid-Atlantic Epilepsy and Sleep Center, LLC

Status and phase: Unknown; Phase 2

Conditions: Diabetes; Obesity; Obstructive Sleep Apnea

Treatments: Drug: Orlistat; Other: Standardized diet; Other: Ketogenic diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02069197

maes 004

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Ketogenic diet, lifestyle counseling

Active Comparator group

Description:

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

Treatment:

Other: Ketogenic diet

Orlistat, Lifestyle counseling

Active Comparator group

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.

Treatment:

Drug: Orlistat

Standartized diet, Lifestyle counseling

Active Comparator group

Description:

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

Treatment:

Other: Standardized diet