Glucose Metabolism Disorders (Including Diabetes Mellitus)NCT04791787
Effect of Ketogenic Diet on Glucose Metabolism and Energy Expenditure in Type 2 Diabetes
A study testing Standard weight maintaining diet, Weight maintaining isocaloric ketogenic diet and Beta-hydroxy butyrate in people with Glucose Metabolism Disorders (Including Diabetes Mellitus) and Energy Supply; Deficiency, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism Disorders (Including Diabetes Mellitus), Energy Supply; Deficiency, Type 2 Diabetes
- What is being tested?
- Standard weight maintaining diet, Weight maintaining isocaloric ketogenic diet and Beta-hydroxy butyrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Nov 2020to 25 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Health Systems-Texas Diabetes Institute
San Antonio, Texas, 78207
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: Effect of Ketogenic Diet on Glucose Metabolism and Energy Expenditure in Type 2 Diabetes CTMS 20-0042
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.
Read the 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 ketogenic diet containing approximately 15-25% protein, 5-10% carbohydrate, 70-80% fat; (3) weight maintaining isocaloric diet containing approximately 15-25% protein, 5-10% carbohydrate, 70-80% fat supplemented with the ketone ester of beta-hydroxy butyrate, 8 grams every 8 hours to further increase the plasma ketone concentration by ~3 mM. Subjects will be further randomized on the basis of:
(i) HbA1c 7.0-8.5% and 8.5-10.5% to ensure similar baseline levels of glucose control and (ii) drug naïve versus drug-treated. At the time of screening, after a 10-12 hour overnight fast, indirect calorimetry will be performed with a ventilated hood system for 60 minutes to measure baseline energy expenditure. An initial weight maintenance energy requirement estimate as 1.5 times resting energy expenditure (obtained by indirect calorimetry) will be started. Diets will consist of a 10-day rotating menu using NutriAdmin for meal planning and Nutrition Maker for analysis of recipes Food will be prepared in the Cafeteria and or the Metabolic Kitchen at the Texas Diabetes Institute and certified by a dietician. Subjects will report to the diet kitchen at 8 AM on Monday through Saturday where they will eat their breakfast and pick up food for their lunch and dinner. On Saturday, participants also will be given food for their Sunday meals. Subjects will maintain a daily dietary log with all food consumed. On each visit subjects will be weighed; dietary log will be reviewed and the caloric content of the diet will be adjusted to maintain the body weight constant. Blood pressure will be measured in the reclining position x 2 separate days. Antidiabetic medications will not be changed during the study unless hypoglycemia (fasting plasma glucose <70 mg/dl or symptoms) occurs. The study duration will be 10 days which should be sufficient to observe the effect of hyperketonemia on glucose/lipid metabolism and energy expenditure. If participant cannot come on the last days of his/her diet treatment, than we will extend this period up to 13 days and participant will be given diet for additional days till completion of the study visits.
- Conditions
- Glucose Metabolism Disorders (Including Diabetes Mellitus), Energy Supply; Deficiency, Type 2 Diabetes
- Being tested
- Standard weight maintaining diet, Weight maintaining isocaloric ketogenic diet, Beta-hydroxy butyrate
- Keywords
- Ketogenic diet, Body fat, Insulin secretion
- Medical subject headings
- Glucose Metabolism Disorders, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard weight maintaining dietOther
Diet containing diet approximately 25-35% protein, 45-55% carbohydrate, 20- 30% fat
Weight maintaining isocaloric ketogenic dietOther
Isocaloric ketogenic diet containing approximately 15-25% protein, 5-10% carbohydrate,70- 80% fat
Beta-hydroxy butyrateDietary supplement
Also called BHOB
A supplement of ketone ester of beta-hydroxy butyrate
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Other: Weight maintaining isocaloric ketogenic diet; Dietary Supplement: Beta-hydroxy butyrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting plasma glucose (FPG)
A change in FPG will be measured
Measured: Baseline to 10 days
Hepatic Glucose production (HGP)
Change of hepatic glucose production will be measured using 3H-glucose infusion
Measured: Baseline to 10 days
Whole Body Fat Oxidation
Change in whole body fat oxidation will be measured using indirect calorimetry
Measured: Baseline to 10 days
Total Body Fat
Change in whole body fat
Measured: Baseline to 10 days
Hepatic Fat Content
Change in hepatic fat content
Measured: Baseline to 10 days
Secondary outcomes (10)
Plasma Insulin
Change in plasma insulin will be measured
Measured: Baseline to 10 days
C-peptide
Change in C-peptide will be measured
Measured: Baseline to 10 days
Free Fatty Acid (FFA)
Change in FFA will be measured
Measured: Baseline to 10 days
Glycerol level
Change in Glycerol level will be measured
Measured: Baseline to 10 days
Low density lipoproteins (LDL)
Change in LDL
Measured: Baseline to 10 days
High density lipoproteins (HDL)
Change in HDL
Measured: Baseline to 10 days
Triglycerides
Change in triglyceride levels
Measured: Baseline to 10 days
Urine Microalbumin excretion
Change in urine microalbumin excretion
Measured: Baseline to 10 days
Glycated hemoglobin test (HbA1c)
Change in HbA1c
Measured: Baseline to 10 days
Fructosamine level
Change in fructosamine
Measured: Baseline to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start25 Nov 2020
- Primary completion25 Apr 2023
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism Disorders (Including Diabetes Mellitus)Studies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized into 3 groups. Each group will be assigned to one of 4 arms.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ralph DeFronzo, MD, Principal investigator, University of Texas Health at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791787
- Sponsor's protocol ID
- HSC20200230H
- Status last verified
- Jun 2024
- First submitted
- 5 Mar 2021
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information will be shared as summary results on ClinicalTrials.gov and in a peer-reviewed scientific journal publication
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ketogenic Diet on Glucose Metabolism and Energy Expenditure in Type 2 Diabetes CTMS 20-0042
- ClinicalTrials.gov ID
- NCT04791787
- Acronym / sponsor ID
- HSC20200230H
- Conditions
- Glucose Metabolism Disorders (Including Diabetes Mellitus), Energy Supply; Deficiency, Type 2 Diabetes
- Keywords
- Ketogenic diet, Body fat, Insulin secretion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 ketogenic diet containing approximately 15-25% protein, 5-10% carbohydrate, 70-80% fat; (3) weight maintaining isocaloric diet containing approximately 15-25% protein, 5-10% carbohydrate, 70-80% fat supplemented with the ketone ester of beta-hydroxy butyrate, 8 grams every 8 hours to further increase the plasma ketone concentration by ~3 mM. Subjects will be further randomized on the basis of:
(i) HbA1c 7.0-8.5% and 8.5-10.5% to ensure similar baseline levels of glucose control and (ii) drug naïve versus drug-treated. At the time of screening, after a 10-12 hour overnight fast, indirect calorimetry will be performed with a ventilated hood system for 60 minutes to measure baseline energy expenditure. An initial weight maintenance energy requirement estimate as 1.5 times resting energy expenditure (obtained by indirect calorimetry) will be started. Diets will consist of a 10-day rotating menu using NutriAdmin for meal planning and Nutrition Maker for analysis of recipes Food will be prepared in the Cafeteria and or the Metabolic Kitchen at the Texas Diabetes Institute and certified by a dietician. Subjects will report to the diet kitchen at 8 AM on Monday through Saturday where they will eat their breakfast and pick up food for their lunch and dinner. On Saturday, participants also will be given food for their Sunday meals. Subjects will maintain a daily dietary log with all food consumed. On each visit subjects will be weighed; dietary log will be reviewed and the caloric content of the diet will be adjusted to maintain the body weight constant. Blood pressure will be measured in the reclining position x 2 separate days. Antidiabetic medications will not be changed during the study unless hypoglycemia (fasting plasma glucose <70 mg/dl or symptoms) occurs. The study duration will be 10 days which should be sufficient to observe the effect of hyperketonemia on glucose/lipid metabolism and energy expenditure. If participant cannot come on the last days of his/her diet treatment, than we will extend this period up to 13 days and participant will be given diet for additional days till completion of the study visits.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Subjects will be randomized into 3 groups. Each group will be assigned to one of 4 arms.
| Arm | Type | Receives |
|---|---|---|
| Standard Weight Maintenance | Active comparator | Other: Standard weight maintaining dietStandard weight maintenance diet will be provided for 10 days for subjects who are not currently treated with a T2DM medication. |
| Isocaloric Diet | Active comparator | Other: Weight maintaining isocaloric ketogenic dietIsocaloric diet will be provided for 10 days for subjects who are currently treated with a T2DM medication included in the inclusion criteria |
| Isocaloric Diet with Beta-hydroxy butyrate | Active comparator | Other: Weight maintaining isocaloric ketogenic diet, Dietary Supplement: Beta-hydroxy butyrateIsocaloric diet with Beta-hydroxy butyrate will be provided for 10 days for subjects who are not currently treated with a T2DM medication. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard weight maintaining dietDiet containing diet approximately 25-35% protein, 45-55% carbohydrate, 20- 30% fat | Other | Standard Weight Maintenance |
| Weight maintaining isocaloric ketogenic dietIsocaloric ketogenic diet containing approximately 15-25% protein, 5-10% carbohydrate,70- 80% fat | Other | Isocaloric Diet, Isocaloric Diet with Beta-hydroxy butyrate |
| Beta-hydroxy butyrateAlso: BHOBA supplement of ketone ester of beta-hydroxy butyrate | Dietary supplement | Isocaloric Diet with Beta-hydroxy butyrate |
Primary outcome
Fasting plasma glucose (FPG)
Time frame: Baseline to 10 days
A change in FPG will be measured
Hepatic Glucose production (HGP)
Time frame: Baseline to 10 days
Change of hepatic glucose production will be measured using 3H-glucose infusion
Whole Body Fat Oxidation
Time frame: Baseline to 10 days
Change in whole body fat oxidation will be measured using indirect calorimetry
Total Body Fat
Time frame: Baseline to 10 days
Change in whole body fat
Hepatic Fat Content
Time frame: Baseline to 10 days
Change in hepatic fat content
10 secondary outcomes
Plasma Insulin
Time frame: Baseline to 10 days
C-peptide
Time frame: Baseline to 10 days
Free Fatty Acid (FFA)
Time frame: Baseline to 10 days
Glycerol level
Time frame: Baseline to 10 days
Low density lipoproteins (LDL)
Time frame: Baseline to 10 days
High density lipoproteins (HDL)
Time frame: Baseline to 10 days
Triglycerides
Time frame: Baseline to 10 days
Urine Microalbumin excretion
Time frame: Baseline to 10 days
Glycated hemoglobin test (HbA1c)
Time frame: Baseline to 10 days
Fructosamine level
Time frame: Baseline to 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: Yes. Information will be shared as summary results on ClinicalTrials.gov and in a peer-reviewed scientific journal publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph DeFronzo, MD principal investigator
University of Texas Health at San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard weight maintaining diet, Weight maintaining isocaloric ketogenic diet and Beta-hydroxy butyrate in people with Glucose Metabolism Disorders (Including Diabetes Mellitus) and Energy Supply; Deficiency, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting plasma glucose (FPG) (time frame: Baseline to 10 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.