Isocaloric Diet with Beta-hydroxy butyrate for Type 2 Diabetes

University Health Systems-Texas Diabetes Institute, San Antonio, TX
Targeting 3 different conditionsBeta-hydroxy butyrate +2 moreN/ARecruitingLed by Ralph DeFronzo, MDResearch Sponsored by The University of Texas Health Science Center at San Antonio

Study Summary

This trial will study the effect of a ketogenic diet on individuals with type 2 diabetes. The team will examine how the body responds to insulin, regulates insulin secretion, food intake and energetic pathways, and influences body fat distribution.

Eligible Conditions
  • Type 2 Diabetes
  • Diabetes Mellitus
  • Energy Deficiency

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Your body mass index (BMI) is between 27.5 and 42 kg/m².
You should be in overall good health.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 10 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 10 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fasting plasma glucose (FPG)
Hepatic Fat Content
Hepatic Glucose production (HGP)
+2 more
Secondary outcome measures
Free Fatty Acid (FFA)
Fructosamine level
+7 more

Awards & Highlights

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

Trial Design

3Treatment groups
Active Control
Group I: Isocaloric Diet with Beta-hydroxy butyrateActive Control2 Interventions
Isocaloric diet with Beta-hydroxy butyrate will be provided for 10 days for subjects who are not currently treated with a T2DM medication.
Group II: Standard Weight MaintenanceActive Control1 Intervention
Standard weight maintenance diet will be provided for 10 days for subjects who are not currently treated with a T2DM medication.
Group III: Isocaloric DietActive Control1 Intervention
Isocaloric diet will be provided for 10 days for subjects who are currently treated with a T2DM medication included in the inclusion criteria

Find a site

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
431 Previous Clinical Trials
83,214 Total Patients Enrolled
Ralph DeFronzo, MDPrincipal Investigator
University of Texas Health at San Antonio
9 Previous Clinical Trials
936 Total Patients Enrolled

Media Library

Weight maintaining isocaloric ketogenic diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04791787 — N/A
Type 2 Diabetes Research Study Groups: Isocaloric Diet with Beta-hydroxy butyrate, Standard Weight Maintenance, Isocaloric Diet
Type 2 Diabetes Clinical Trial 2023: Weight maintaining isocaloric ketogenic diet Highlights & Side Effects. Trial Name: NCT04791787 — N/A
Weight maintaining isocaloric ketogenic diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04791787 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have signed up for this research project?

"Indeed, clinicaltrials.gov has updated the listing to demonstrate that this study is actively searching for volunteers. The trial was first available on November 25th 2020 and most recently amended on October 10th 2022 with two sites looking to recruit 30 participants in total."

Answered by AI

What goals does this clinical experiment aim to accomplish?

"This trial's primary goal, assessed over the time frame of Baseline to 10 days, is to assess Whole Body Fat Oxidation. Subsidiary aims include studying changes in Glycerol level, High Density Lipoproteins (HDL), and C-peptide levels."

Answered by AI

Is eligibility for this study limited to individuals above a certain age threshold?

"This clinical trial is exclusively for patients between the ages of 18 to 70. Although, there are a total of 1380 trials available for those under 18 and over 65 combined."

Answered by AI

What criteria must individuals meet in order to be eligible for this trial?

"To be eligible to take part in this diabetes mellitus trial, potential participants must be aged 18-70. This research study is seeking approximately 30 individuals."

Answered by AI

Are there any available spots to join this research endeavor?

"Affirmative. Clinicaltrials.gov's records demonstrate that this clinical trial is seeking volunteers to participate, with the original post dating back to November 25th 2020 and a recent update posted on October 10th 2022. The study requires 30 participants from two distinct locations."

Answered by AI

Who else is applying?

What state do they live in?
What portion of applicants met pre-screening criteria?
Met criteria
~8 spots leftby Oct 2024