NCT04955691Completed
Metabolic Changes Induced by a Very Low Carbohydrate Diet in Youth With Type 1 Diabetes
Metabolic and Neurological Changes Induced by a Very Low Carbohydrate Diet in Youth With Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 16 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 19 (actual)
- First submitted
- 1 Jul 2021
- Start date
- 29 Jul 2021
- Primary completion date
- 6 Aug 2024
- Lead sponsor
- Yale University
- Diseases
- Type 1 diabetes
- NCT number
- NCT04955691
What you commit to
- Study type: Interventional
- Participants enrolled: 19
- From 29 Jul 2021 to the primary completion date, 6 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Weight loss medications within the last 6 months
Other illness
- Unstable psychiatric disorders, including eating disorders
Lab values
- Current use of glucose-lowering agents other than insulin
- Other medical conditions that may interfere with glucose metabolism and insulin sensitivity
Age
- BMI \< 19 kg/m2 for individuals 18 years of age or older
Other
- Pregnancy or lactation, or planning pregnancy within the next 6 months
- BMI \< 5%ile for individuals under 18 years
- Weight less than 49 kg or 108 pounds
Who the study is looking for
- 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
Age in the registry: 12 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yale New Haven Hospital Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.