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Very Low Carbohydrate Diets and Glucagon Response in Type 1 Diabetes

This study is looking at how a very low carbohydrate diet affects the body's response to glucagon in people with Type 1 Diabetes (T1D). Glucagon is a hormone that helps raise blood sugar. Researchers want to see if this diet helps glucagon successfully raise blood sugar to a safe level (at least 70 mg/dL or an increase of 20 mg/dL) within 30 minutes. You might be able to join if you are 18-40 years old, have T1D for at least a year, use a continuous glucose monitor (CGM) and an insulin pump, and have stable blood sugar control (HbA1c 6.5-9%). All meals will be provided, along with fiber, multivitamins, magnesium, and omega-3 supplements. The study aims to enroll 12 participants, but the current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 12 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will exclusively consume study foods, which include a very low carbohydrate diet, fiber supplements, and daily multi-vitamin, magnesium, and omega-3 supplements. The primary endpoint is measured at week 5-12 on the diet.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at week 5-12 on the very low carbohydrate diet. Further follow-up is not specified.

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NCT04200391

Very Low Carbohydrate Diets and Glucagon Response in T1DM

Recruiting
NAAges 18–40InterventionalSupportive care
Boston Children's Hospital
~12 participants
Updated 2024-12-18 on ClinicalTrials.gov
What's tested:Very low carbohydrate diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Glucagon treatment success, defined as an increase in glucose level to ≥ 70 mg/dL or an Increase of ≥ 20 mg/dL from glucose nadir within 30 minutes after receiving 1 mg glucagon IM
Measured over week 5-12 on the very low carbohydrate diet

Conditions

Type1diabetes

Explore related trials

Type 1 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Belinda S Lennerz · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital

Who to contact

Belinda S Lennerz, MD, PhD
[email protected]
8572183896 · ext. 6173557476
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Eligibility criteria

Inclusion

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

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:

What this trial measures

  • Glucagon treatment success, defined as an increase in glucose level to ≥ 70 mg/dL or an Increase of ≥ 20 mg/dL from glucose nadir within 30 minutes after receiving 1 mg glucagon IMweek 5-12 on the very low carbohydrate diet

    Point-of-care blood glucose levels will be measured pre-dose and every 5 minutes for 30 minutes and until BG is ≥ 70 mg/dL (whichever occurs later), then gradually spaced per MD orders to align with the rest of the labs