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Lay Description

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

  • Diabetes
  • Nutrition
  • Obesity
IRB Number
20200230HU
NCT Number
NCT04791787
Open to Enrollment
Yes

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

Arm Groups

Study Contact


Regulatory Point of Contact
Ralph DeFronzo
(210) 567-6691
defronzo@uthscsa.edu

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

Local Recruitment Point of Contact
Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu

Overall Recruitment Point of Contact
Aurora Merovci
2105676691
merovci@uthscsa.edu

Principal Investigator
Ralph DeFronzo