Effect of Ketogenic Diet on Glucose Metabolism and Energy Expenditure in Type 2 Diabetes (NCT04791787) | Clinical Trial Compass
CompletedNot Applicable
Effect of Ketogenic Diet on Glucose Metabolism and Energy Expenditure in Type 2 Diabetes
United States35 participantsStarted 2020-11-25
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Use of medications that affect glucose tolerance other than metformin/sulfonylurea/DPP4 Inhibitor
. Major organ disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fasting plasma glucose (FPG)
Timeframe: Baseline to 10 days
2
Hepatic Glucose production (HGP)
Timeframe: Baseline to 10 days
3
Whole Body Fat Oxidation
Timeframe: Baseline to 10 days
4
Total Body Fat
Timeframe: Baseline to 10 days
5
Hepatic Fat Content
Timeframe: Baseline to 10 days
Trial details
NCT IDNCT04791787
SponsorThe University of Texas Health Science Center at San Antonio