NCT04791787

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2023

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

2.4 years

First QC Date

March 5, 2021

Last Update Submit

June 10, 2024

Conditions

Glucose Metabolism Disorders (Including Diabetes Mellitus)Energy Supply; DeficiencyType 2 Diabetes

Keywords

Ketogenic dietBody fatInsulin secretion

Outcome Measures

Primary Outcomes (5)

  • Fasting plasma glucose (FPG)

    A change in FPG will be measured

    Baseline to 10 days

  • Hepatic Glucose production (HGP)

    Change of hepatic glucose production will be measured using 3H-glucose infusion

    Baseline to 10 days

  • Whole Body Fat Oxidation

    Change in whole body fat oxidation will be measured using indirect calorimetry

    Baseline to 10 days

  • Total Body Fat

    Change in whole body fat

    Baseline to 10 days

  • Hepatic Fat Content

    Change in hepatic fat content

    Baseline to 10 days

Secondary Outcomes (10)

  • Plasma Insulin

    Baseline to 10 days

  • C-peptide

    Baseline to 10 days

  • Free Fatty Acid (FFA)

    Baseline to 10 days

  • Glycerol level

    Baseline to 10 days

  • Low density lipoproteins (LDL)

    Baseline to 10 days

  • +5 more secondary outcomes

Study Arms (3)

Standard Weight Maintenance

ACTIVE COMPARATOR

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

Isocaloric Diet

ACTIVE COMPARATOR

Isocaloric diet will be provided for 10 days for subjects who are currently treated with a T2DM medication included in the inclusion criteria

Other: Weight maintaining isocaloric ketogenic diet

Isocaloric Diet with Beta-hydroxy butyrate

ACTIVE COMPARATOR

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

Other: Weight maintaining isocaloric ketogenic dietDietary Supplement: Beta-hydroxy butyrate

Interventions

Standard weight maintaining dietOTHER

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

Standard Weight Maintenance
Weight maintaining isocaloric ketogenic dietOTHER

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

Isocaloric DietIsocaloric Diet with Beta-hydroxy butyrate
Beta-hydroxy butyrateDIETARY_SUPPLEMENT

A supplement of ketone ester of beta-hydroxy butyrate

Also known as: BHOB
Isocaloric Diet with Beta-hydroxy butyrate

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Health Systems-Texas Diabetes Institute

San Antonio, Texas, 78207, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Glucose Metabolism DisordersDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Study Officials

  • Ralph DeFronzo, MD

    University of Texas Health at San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Subjects will be randomized into 3 groups. Each group will be assigned to one of 4 arms.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 10, 2021

Study Start

November 25, 2020

Primary Completion

April 25, 2023

Study Completion

April 25, 2023

Last Updated

June 11, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

Information will be shared as summary results on ClinicalTrials.gov and in a peer-reviewed scientific journal publication

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After study completion

Locations

US(2)