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NCT04200391 · ClinicalTrials.gov registry record · NA
Very Low Carbohydrate Diets and Glucagon Response in T1DM
A NA study of Type1diabetes, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT04200391 is a NA study of Type1diabetes that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 12 participants, below the 261-participant average among 19 other Type1diabetes trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04200391, a NA study of Type1diabetes, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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 (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 adequate while following a VLC diet in the longer term, the investigators will conduct a glucagon challenge in participants who are assigned to the VLC arm of a randomized-controlled feeding study in 32 young adults with T1D who will receive a VLC vs a standard diet for 12 weeks. After an overnight fast, twelve participants in the VLC arm will receive IV insulin to lower blood glucose levels to 60 mg/dL, followed by a glucagon injection and monitoring of blood glucose levels and other metabolic fuels
Conditions Studied
Interventions
- OTHER Very low carbohydrate diet
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-01-03 |
| Est. Completion | 2026-07-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04200391
The ClinicalTrials.gov registry entry for NCT04200391 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 19 other Type1diabetes trials with a reported enrollment target (95% lower). The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Type1diabetes appearing as the primary indexed condition, and to 1 intervention - of which Very low carbohydrate diet is the first listed.
NCT04200391 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04200391 about?
NCT04200391 is a clinical study titled "Very Low Carbohydrate Diets and Glucagon Response in T1DM". 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 period...
What is the current status of trial NCT04200391?
This trial is currently recruiting. It is a NA study. The enrollment target is 12 participants. The study started on 2020-01-03. Estimated completion is 2026-07-31.
What conditions does trial NCT04200391 study?
This clinical trial studies the following conditions: Type1diabetes.
What interventions are being tested in trial NCT04200391?
The interventions under investigation include: Very low carbohydrate diet (OTHER).
Who is sponsoring clinical trial NCT04200391?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04200391 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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