Effect of Dietary Carbohydrate on Diabetes Control and Beta Cell Function in Children With Newly Diagnosed Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to test the effects of a ketogenic diet on the progression and control of type 1 diabetes in children with newly diagnosed diabetes. The main questions to answer are: * Does a ketogenic diet prolong the honeymoon period of type 1 diabetes? * Does a ketogenic diet improve diabetes control? * Is a ketogenic diet safe, acceptable and sustainable in children with newly diagnosed diabetes? * What are the microbiome, inflammatory and metabolic changes linking diet to β-cell function? Participants will receive a combination of free meals, groceries, micronutrient supplements, and intensive diet and diabetes education for 9 months. * Diabetes care devices will be connected for cloud-based data collection. * Bi-weekly data downloads and remote check-ins will assess dietary intake, satisfaction with diet and study procedures, and possible safety concerns. * During four study visits held at at baseline, 1, 5, and 9 months, an intravenous catheter (IV) will be placed for collection of 5 blood samples before and up to 2 hours after a liquid test meal (protein shake) to assess insulin response. A stool sample will also be collected to assess microbiome changes. * Children and their caregivers may be invited to participate in a semi-structured interview, and online questionnaires to assess their experience with the diet and diabetes care, general well-being and quality of life. * Children and their caregivers may be invited to participate in a follow-up visit to evaluate long-term effects after 24 months. Comparison will be made between a ketogenic vs standard diet.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 12
Healthy Volunteers: f
View:

• Children aged 5 to 12 years.

• Within 3 month of diabetes diagnosis.

• Insulin adjusted HbA1c ≤9 if enrolled ≥ 2 months pat diagnosis.

• Type 1 diabetes confirmed by immediate insulin requirement and any 2 of the following criteria: autoimmunity marker \[glutamate decarboxylase-65, islet-antigen-2, zinc transporter-8, insulin \[prior to first insulin dose\]; age under 10 years, BMI \<95th percentile.

• Family committed and able to participate in study education and implement dietary intervention.

Locations
United States
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Contact Information
Primary
Belinda Lennerz, MD PhD
belinda.lennerz@childrens.harvard.edu
857-218-3896
Time Frame
Start Date: 2024-05-31
Estimated Completion Date: 2029-04-30
Participants
Target number of participants: 52
Treatments
Experimental: ketogenic diet
The diet will be high in protein and healthy fats and comprise meat, fish, fibrous vegetables, nuts, dairy, and berries. Macronutrient composition will be \~ 5% carbohydrate, 20% protein, 70% fat.~Participants will receive a daily multi-vitamin, magnesium supplement, and supplemental salt (bouillon cubes) to ascertain micronutrient sufficiency and help with transition to the diet.
Active_comparator: standard diet
The diet will be consistent with prevailing dietary guidelines and recommendations and contain meat, fish, grains, vegetables, fruit and dairy. At least 50% of grain-based products will be whole grains. Meats will be primarily lean, and dairy products will be fat-free or low-fat. Macronutrient composition will be \~50% carbohydrate (\<10% added sugars), 20% protein, 30% fat.~Participants will receive a daily multi-vitamin supplement to ascertain micronutrient sufficiency.
Related Therapeutic Areas
Sponsors
Collaborators: Indiana University, University of South Florida
Leads: Boston Children's Hospital

This content was sourced from clinicaltrials.gov