Exploring very low carbohydrate diets for managing Type 1 diabetes
Glucagon Response in Patients With Type 1 Diabetes Mellitus Following a Very Low Carbohydrate
This study is testing if a very low carbohydrate diet can help adults with Type 1 diabetes manage their blood sugar levels better and reduce the need for insulin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04200391 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a very low carbohydrate diet on glucagon response in individuals with Type 1 diabetes (T1D). It aims to address the challenges of glycemic control by potentially reducing post-meal blood glucose fluctuations and insulin requirements. Participants will be adults aged 18 to 40 with stable glycemic control who use continuous glucose monitors and insulin pumps. The study will assess the safety and efficacy of this dietary approach in managing T1D complications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 40 with Type 1 diabetes for at least one year, stable glycemic control, and who use continuous glucose monitors and insulin pumps.
Not a fit: Patients with recent severe hypoglycemia, dietary restrictions incompatible with the study diet, or those following a weight-loss diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved glycemic control and reduced risk of complications for patients with Type 1 diabetes.
How similar studies have performed: Previous studies have shown promising results with very low carbohydrate diets in managing Type 1 diabetes, but this specific approach remains somewhat controversial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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 * Following a weight-loss or otherwise restrictive diet * Vigorous exercise \>2 hours on \>3 days a week * 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 * Smoking, use of recreational drugs, or excessive alcohol consumption * Pregnancy or breastfeeding * Anemia * For participants who undergo MRI: 1. Standard MRI exclusion criteria 2. Irregular menses 3. 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).
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Belinda S Lennerz — Boston Children's Hospital
- Study coordinator: Belinda S Lennerz, MD, PhD
- Email: belinda.lennerz@childrens.harvard.edu
- Phone: 8572183896
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.