NCT03710928Recruiting
Type 1 Diabetes Management Using a Very Low Carbohydrate Versus Standard Diet
Source: ClinicalTrials.gov · Last updated 18 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Despite major technological advances, management of type one diabetes mellitus (T1D) remains suboptimal, putting millions of people at risk for immediate and long-term complications. After meals, a mismatch between carbohydrate absorption rate and insulin action typically leads to alternating periods of hyper- and hypoglycemia. A conceptually promising approach to control both problems is dietary carbohydrate restriction to reduce postprandial blood glucose changes and insulin needs. In a prior survey study, the investigators documented exceptional glycemic control (HbA1c 5.67%) and low acute complication rates among 316 children and adults with T1D consuming a very-low-carbohydrate diet. To test the feasibility of this approach, the investigators will conduct a randomized-controlled feeding study involving 32 adults and adolescents with T1D. Participants will be randomized to receive a very low carbohydrate vs. standard carbohydrate diet. Participants will be in the study for 12 weeks and receive all their meals by meal delivery.They will share continuous glucose monitoring data with the study team and be in close communication to adjust insulin doses as needed. All participants will have a screening visit, an individual or group education session, and 3 study visits to evaluate diabetes control and metabolic health. Some of these visits will have a fasting blood draw. Two of the visits will also comprise additional metabolic studies to assess glucagon response and brain function during hypoglycemia by magnetic resonance imaging (MRI). Participants will have IV catheters placed and receive IV insulin to drop blood glucose levels to 50 mg/dl for up to 30 minutes. The primary outcome will be HbA1c change from baseline. Secondary outcomes include detailed measures of glycemic variability, metabolic health, and quality of life.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 16 Oct 2018
- Start date
- 3 Jan 2020
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Boston Children's Hospital
- Diseases
- Type 1 diabetes
- NCT number
- NCT03710928
What you commit to
- Study type: Interventional
- Planned participants: 32
- From 3 Jan 2020 to the primary completion date, 31 Jul 2026
- 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
- Smoking, use of recreational drugs, or excessive alcohol consumption
- For participants who undergo MRI:
- Standard MRI exclusion criteria
- Irregular menses
- Use of psychotropic medication other than SSRIs or other mild antidepressant or anxiety medications (unless these medications are safe to be held for several days to allow for the acquisition of MRI data)
Other illness
- Ketoacidosis or severe hypoglycemia with seizure or coma in the past 6 months
- Dietary restrictions or intolerances that are incompatible with the planned food deliveries, e.g. celiac disease, gastroparesis, certain food allergies
- History of an eating disorder or at risk for eating disorder, assessed by the Eating Disorders Diagnostic Scale (EDDS)
- Major medical illness or use of medications other than insulin and metformin that could interfere with metabolic or glycemic variables
- Significant psychiatric illness
Other
- Following a weight-loss or otherwise restrictive diet
- Vigorous exercise \>2 hours on \>3 days a week
- Pregnancy or breastfeeding
- Anemia
Who the study is looking for
- Males and females with T1D for at least 1 year
- Age 18 to 40 years
- Tanner stage ≥ IV
- BMI 18.5-35 kg/m2
- Stable glycemic control (HbA1c 6.5-9%)
- Use of a continuous glucose monitor (CGM)
- Use of an insulin pump
- Attendance of at least 1 diabetes care visit over the past 12 months (including virtual)
Age in the registry: 18 years to 40 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.