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



Status:Recruiting
Conditions:Insomnia Sleep Studies, Obesity Weight Loss, Pulmonary, Pulmonary, Diabetes, Diabetes
Therapuetic Areas:Endocrinology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 70
Updated:8/19/2018
Start Date:January 2014
End Date:September 2020
Contact:Ivana Tyrlikova, MD
Email:tyrlikovai@epilepsydc.com
Phone:301-530-9744

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Trial Summary
Trial Overview
Inclusion Criteria

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

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).

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.

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.
We found this trial at
1
site
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland 20817
Phone: 301-530-9744
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from
Bethesda, MD
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