Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea (KGDobesity)
Obesity, Diabetes, Obstructive Sleep Apnea
About this trial
This is an interventional treatment trial for Obesity focused on measuring ketogenic diet, obesity, diabetes, obstructive sleep apnea
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.
Sites / Locations
- Mid-Atlantic Epilepsy and Sleep Center, LLCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Ketogenic diet, lifestyle counseling
Orlistat, Lifestyle counseling
Standartized diet, Lifestyle counseling
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.