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3:1 Ketogenic Complete Meal Replacement for Obesity
N/A
Waitlist Available
Led By Pavel Klein, M.B,B.Chir.
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
Age 18-70
Ability and willingness to sign informed consent form.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 3 and 6 months treatment duration
Awards & highlights
Study Summary
The purpose of the study is to evaluate the efficacy and safety of ketogenic diet (KD) complete meal replacement treatment of obesity-related Type 2 diabetes mellitus (T2DM) and of obesity in patients with obesity and T2DM. This will be an open-label single arm study evaluating glycemic control and weight loss in obese participants with type 2 diabetes treated for 6 months with 3:1 [fat]:[protein+carbohydrate] ratio, 1600 kcal/day diet.
Eligible Conditions
- Obesity
- Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0, 3 and 6 months treatment duration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 3 and 6 months treatment duration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Type 2 diabetes remission
Secondary outcome measures
Adverse events
BMI
Blood pressure
+10 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: 3:1 Ketogenic Complete Meal ReplacementExperimental Treatment1 Intervention
Evaluating glycemic control and weight loss in obese participants with type 2 diabetes treated for 6 months with 3:1 [fat]:[protein+carbohydrate] ratio, 1600 kcal/day complete meal replacement ketogenic diet
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Who is running the clinical trial?
Mid-Atlantic Epilepsy and Sleep Center, LLCLead Sponsor
8 Previous Clinical Trials
366 Total Patients Enrolled
1 Trials studying Obesity
150 Patients Enrolled for Obesity
Pavel Klein, M.B,B.Chir.Principal InvestigatorMid-Atlantic Epilepsy and Sleep Center
1 Previous Clinical Trials
8 Total Patients Enrolled
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