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Ketogenic diet, lifestyle counseling for Obesity (KGDobesity Trial)

Phase 2
Waitlist Available
Led By Pavel Klein, M.D.
Research Sponsored by Mid-Atlantic Epilepsy and Sleep Center, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

KGDobesity 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).

Eligible Conditions
  • Obesity
  • Diabetes
  • Obstructive Sleep Apnea

KGDobesity Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change of body mass index from baseline in 9 months period
Secondary outcome measures
Change from baseline in glucose blood level in patients with diabetes mellitus in 9 months.
Change of apnea/hypopnea index in patients with obstructive sleep apnea in patients with obesity
To evaluate safety of ketogenic diet as a treatment of obesity.

KGDobesity Trial Design

3Treatment groups
Active Control
Group I: Ketogenic diet, lifestyle counselingActive Control1 Intervention
ketogenic diet consisted of 3:1[fat]:[protein+carbohydrate] weight ratio with 1600kcal restriction.
Group II: Orlistat, Lifestyle counselingActive Control1 Intervention
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.
Group III: Standartized diet, Lifestyle counselingActive Control1 Intervention
Standardized diet and lifestyle-modification counseling based on the LEARN (Lifestyle, Exercise, Attitudes, Relationship, Nutrition) program with recommended caloric goal of 1600kcal/day.

Find a Location

Who is running the clinical trial?

Mid-Atlantic Epilepsy and Sleep Center, LLCLead Sponsor
8 Previous Clinical Trials
266 Total Patients Enrolled
1 Trials studying Obesity
50 Patients Enrolled for Obesity
Pavel Klein, M.D.Principal InvestigatorMid-Atlantic Epilepsy and Sleep center
5 Previous Clinical Trials
194 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea
Pavel Klein 2014. "Ketogenic Diet Treatment of Obesity With Co-morbid Type 2 Diabetes Mellitus and/or Obstructive Sleep Apnea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02069197.
All > Apnea > Xenical
~13 spots leftby Apr 2025
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