Purpose

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 insulin secretion, food intake and energetic pathways and influences body fat distribution.

Category

IRB Number
20200230HU
NCT Number
NCT04791787
Open to Enrollment
Yes
Sponsor
The University of Texas Health Science Center at San Antonio -



Study Contact

Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu

Aurora Merovci
2105676691
merovci@uthscsa.edu

Principal Investigator
Ralph DeFronzo

Ralph DeFronzo
(210) 567-6691
defronzo@uthscsa.edu

Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu



Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

    1. Age from 18-70 years
    2. BMI = 27.5-42 kg.m2
    3. HbA1c = 7.0-10.5
    4. Weight stable (±4-5lb) in the preceding 3 months
    5. Good general health

Exclusion Criteria

    1. Use of medications that affect glucose tolerance other than metformin/sulfonylurea/DPP4 Inhibitor
    2. Major organ disease
    3. Estimated Glomerular filtration rate (eGFR) <60 ml/min
    4. Type 1 diabetes
    5. Hematocrit < 34 (if HbA1c is in the 8.5 to 10% range)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Subjects will be randomized into 3 groups. Each group will be assigned to one of 4 arms.
Primary Purpose
Other
Masking
None (Open Label)
Condition
  • Glucose Metabolism Disorders (Including Diabetes Mellitus)
  • Energy Supply; Deficiency
  • Type 2 Diabetes
  • Arm Groups

    ArmDescriptionIntervention
    Active Comparator

    Isocaloric Diet

    Isocaloric diet will be provided for 10 days for subjects who are currently treated with a T2DM medication included in the inclusion criteria
  • Dietary Supplement: Beta-hydroxy butyrate

    A supplement of ketone ester of beta-hydroxy butyrate

    Other names:

    • BHOB

  • Other: Weight maintaining isocaloric ketogenic diet

    Isocaloric ketogenic diet containing approximately 15-25% protein, 5-10% carbohydrate,70- 80% fat

  • Active Comparator

    Standard Weight Maintenance

    Standard weight maintenance diet will be provided for 10 days for subjects who are not currently treated with a T2DM medication.
  • Other: Standard weight maintaining diet

    Diet containing diet approximately 25-35% protein, 45-55% carbohydrate, 20- 30% fat

  • Active Comparator

    Isocaloric Diet with Beta-hydroxy butyrate

    Isocaloric diet with Beta-hydroxy butyrate will be provided for 10 days for subjects who are not currently treated with a T2DM medication.
  • Dietary Supplement: Beta-hydroxy butyrate

    A supplement of ketone ester of beta-hydroxy butyrate

    Other names:

    • BHOB

  • Other: Weight maintaining isocaloric ketogenic diet

    Isocaloric ketogenic diet containing approximately 15-25% protein, 5-10% carbohydrate,70- 80% fat