Status:
COMPLETED
Effect of Ketogenic Diet on Glucose Metabolism and Energy Expenditure in Type 2 Diabetes
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Conditions:
Glucose Metabolism Disorders (Including Diabetes Mellitus)
Energy Supply; Deficiency
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The study team will examine the effect of a ketogenic diet alone and ketogenic diet supplemented with oral ketones on how the body of individuals with type 2 diabetes respond to insulin, regulates ins...
Detailed Description
Subjects will be randomized into three groups (1) standard, weight maintaining diet containing approximately 25-35% protein, 45-55% carbohydrate, 20-30% fat; (2) weight maintaining isocaloric ketogeni...
Eligibility Criteria
Inclusion
- Age from 18-70 years
- BMI = 27.5-42 kg.m2
- HbA1c = 7.0-10.5
- Weight stable (±4-5lb) in the preceding 3 months
- Good general health
Exclusion
- Use of medications that affect glucose tolerance other than metformin/sulfonylurea/DPP4 Inhibitor
- Major organ disease
- Estimated Glomerular filtration rate (eGFR) \<60 ml/min
- Type 1 diabetes
- Hematocrit \< 34 (if HbA1c is in the 8.5 to 10% range)
Key Trial Info
Start Date :
November 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2023
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04791787
Start Date
November 25 2020
End Date
April 25 2023
Last Update
June 11 2024
Active Locations (2)
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1
University Health Systems-Texas Diabetes Institute
San Antonio, Texas, United States, 78207
2
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229