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Study identifier: NCT04200391 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Very Low Carbohydrate Diets and Glucagon Response in T1DM

Condition: Type1diabetes  ·  Sponsor: Boston Children's Hospital

PhaseNA
Planned participants12
Who can joinAll sexes, 18 Years to 40 Years
Healthy volunteersNo

About this study

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 (VLC) diet. Despite these promising preliminary results, the use of VLC diets for T1D remain controversial, because of their restrictive nature and theoretical concerns regarding growth, ketoacidosis and hypoglycemia risks and efficiency of glucagon treatment for hypoglycemia. Glucagon is used as a rescue medication during severe hypoglycemia and increases blood glucose levels by mobilizing liver glycogen stores. If these stores are depleted during carbohydrate restriction, glucagon response may be inadequate and put individuals at risk for refractory hypoglycemia. A physiologic study has shown a blunted but still adequate response to glucagon in n=10 participants after following a VLCD for 1 week. Longer-term studies have not been done. To test the hypotheses that glucagon response remains adequ…

This description comes directly from the study's public registry record.

Talk to the study team

Belinda S Lennerz, MD, PhD  ·  8572183896  ·  belinda.lennerz@childrens.harvard.edu

Always discuss trial participation with your own doctor first.

Locations (1)

Boston Children's HospitalBoston, Massachusetts, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT04200391