Metabolic Changes Induced by a Very Low Carbohydrate Diet in Youth With Type 1 Diabetes (NCT04955691) | Clinical Trial Compass
CompletedNot Applicable
Metabolic Changes Induced by a Very Low Carbohydrate Diet in Youth With Type 1 Diabetes
United States19 participantsStarted 2021-07-29
Plain-language summary
As more adolescents with type 1 diabetes (T1D) opt to follow very low carbohydrate diets to improve glucose control, it is becoming increasingly important to study the metabolic and neurological changes that occur on these diets and how these effect patient safety. Understanding the impact of dietary changes on metabolic and neurological factors will help guide clinical advice about the overall safety and efficacy of these diets in the pediatric T1D population. This work will be the basis of future studies testing dietary interventions to improve glycemic control and ensure that these dietary interventions are safe for growing youth with T1D.
Who can participate
Age range
12 Years – 21 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:
* Diagnosis of type 1 diabetes for at least 1 year
* Hemoglobin A1c level \< 10% within the past 2 months
* Provision of signed and dated informed consent form by the adult (if person is at least 18 years old) or parent and assent form if the participant is \<18 years old.
* Stated willingness to comply with all study procedures and availability for the duration of the study
* All sexes are eligible
* Diagnosis of type 1 diabetes for at least 1 year
* Insulin pump use for at least 2 months.
* Ability to perform daily blood ketone checks, wear a continuous glucose monitor, willing to wear an activity monitor, willing to adhere to the study diets and keep a diet journal.
* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of the dietary intervention.
* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
Exclusion Criteria:
* Current use of glucose-lowering agents other than insulin
* Unstable psychiatric disorders, including eating disorders
* Weight loss medications within the last 6 months
* Pregnancy or lactation, or planning pregnancy within the next 6 months
* BMI \< 19 kg/m2 for individuals 18 years of age or older
* BMI \< 5%ile for individuals under 18 years
* Weight less than 49 kg or 108 pounds
* Other medical co…
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.