RecruitingNot ApplicableNCT03710928

Type 1 Diabetes Management Using a Very Low Carbohydrate Versus Standard Diet


Sponsor

Boston Children's Hospital

Enrollment

32 participants

Start Date

Jan 3, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing a very low-carbohydrate diet to a standard diabetes diet in young adults with type 1 diabetes who use an insulin pump and continuous glucose monitor, to see if a low-carb approach can improve blood sugar control and reduce the burden of managing diabetes day to day. **You may be eligible if...** - You are between 18 and 40 years old with type 1 diabetes (for at least 1 year) - You use both an insulin pump and a continuous glucose monitor (CGM) - Your HbA1c (a 3-month blood sugar average) is between 6.5% and 9% - You have had at least one diabetes care visit in the past 12 months - Your BMI is between 18.5 and 35 **You may NOT be eligible if...** - You have had a serious low blood sugar event with seizure or coma in the past 6 months - You have dietary restrictions incompatible with the study foods (like celiac disease or certain food allergies) - You are following a weight-loss or very restrictive diet - You exercise vigorously for more than 2 hours on more than 3 days per week - You have an eating disorder or are at risk for one - You are pregnant or breastfeeding - You smoke, use recreational drugs, or drink excessively Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERvery low carbohydrate diet

All meals will be delivered and participants will consume study foods exclusively. Participants will receive a fiber supplement as needed with each meal to support digestive health, and a daily multi-vitamin, magnesium and omega-three supplement to ascertain micronutrient sufficiency. Participants will be weighed at each study visit and the diet plan will be adjusted for satiety and weight-maintenance. The diet composition will be as follows: 5% carbohydrate, 70% fat, 20% protein.

OTHERstandard carbohydrate diet

All meals will be delivered and participants will consume study foods exclusively. Participants will receive a daily multi-vitamin and omega-3 supplement to ascertain micronutrient sufficiency. Participants will be weighed at each study visit and the diet plan will be adjusted for satiety and weight-maintenance. The diet composition will be as follows: 50% carbohydrate, 30% fat, 20% protein.


Locations(1)

Boston Children's Hospital

Boston, Massachusetts, United States

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NCT03710928


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