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

• Status: Unknown status
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mid-Atlantic Epilepsy and Sleep Center, LLC
• Treatments: Orlistat

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.