Treatment of Type 2 Diabetes With Ketogenic Diet
NCT03652649 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2018-08-29
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.
Conditions
- Type2 Diabetes Mellitus
- Obesity
Interventions
- OTHER
-
3:1 ratio Ketogenic diet
Type 2 Diabetic subjects with BMI greater than or equal to 30 are started on 3:1 ratio ketogenic complete meal replacement program and weight loss and glycemic control is tracked over 6 month intervention period
Sponsors & Collaborators
-
Mid-Atlantic Epilepsy and Sleep Center, LLC
lead OTHER
Principal Investigators
-
Pavel Klein, M.B,B.Chir. · Mid-Atlantic Epilepsy and Sleep Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-11-01
- Primary Completion
- 2020-11-01
- Completion
- 2020-11-01
Countries
- United States
Study Locations
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