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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 3 and 6 months treatment duration
Awards & highlights
No Placebo-Only Group

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
  • Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 3 and 6 months treatment duration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 3 and 6 months treatment duration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Type 2 diabetes remission
Secondary study objectives
Adverse events
BMI
Blood pressure
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
~6 spots leftby Nov 2025
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