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Very Low Carbohydrate Diets and Glucagon Response in T1DM 12 Randomized Dietary

Recruiting
Clinical Trial NCT04200391 is an interventional study for Type1diabetes that is recruiting. It started on January 3, 2020 with plans to enroll 12 participants. Led by Boston Children's Hospital, it is expected to complete by July 31, 2026. The latest data from ClinicalTrials.gov was last updated on December 18, 2024.
Brief 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 restric...Show More
Official Title

Glucagon Response in Patients With Type 1 Diabetes Mellitus Following a Very Low Carbohydrate

Conditions
Type1diabetes
Other Study IDs
  • IRB-P00030039_3
NCT ID Number
NCT04200391
Start Date (Actual)
2020-01-03
Last Update Posted
2024-12-18
Completion Date (Estimated)
2026-07-31
Enrollment (Estimated)
12
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
nutrition
very low carbohydrate diet
ketogenic diet
nutritional ketosis
glucagon
hypoglycemia
glycogen
ketosis
ketones
Primary Purpose
Supportive Care
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalVery low carbohydrate diet
Dietary Intervention, food delivery
Very low carbohydrate diet
All meals will be delivered and participants will consume study foods exclusively. Participants will receive a fiber supplement with each meal as needed to promote digestive health, and a daily multi-vitamin, magnesium 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 composit...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
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
week 5-12 on the very low carbohydrate diet
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Recovery from symptoms of hypoglycemia
Recovery from hypoglycemia symptoms will be assessed using a Hypoglycemia Symptoms Scale at baseline, when blood glucose is \< 75 mg/dL, pre-dose, and at 15, 30, 45, 60, 75, and 90 minutes following administration of glucagon. The Hypoglycemia Symptoms Scale measures the intensity of 14 commonly experienced hypoglycemic symptoms on a scale from 0 (not present) to 6 (very intense). The higher the score, the more intense the hypoglycemia symptoms. The sum of each symptom score would yield a range of 0 to 84 (e.g., 14 x 6 = 84). The total score will be calculated as the sum of each symptom score and summarized at each time point.
week 5-12 on the very low carbohydrate diet
Time to achieve glucagon treatment success
The mean time from glucagon administration to blood glucose ≥ 70 mg/dL or an increase ≥ 20 mg/dL in blood glucose from nadir. 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.
week 5-12 on the very low carbohydrate diet
Plasma levels of beta-hydroxybutyrate following glucagon administration
Levels will be measured at baseline, pre-dose, and at 10, 20, 30, 45, 60, and 90 minutes. Average levels at each time point, peak level, and area under the curve (AUC) will be reported.
week 5-12 on the very low carbohydrate diet
Plasma levels of free fatty acids following glucagon administration
Levels will be measured at baseline, pre-dose, 10, 20, 30, 45, 60, and 90 minutes. Average levels at each time point, peak level, and area under the curve (AUC) will be reported.
week 5-12 on the very low carbohydrate diet
Plasma glucose levels following glucagon administration
Levels will be measured at baseline, pre-dose, and at 10, 20, 30, 45, 60, and 90 minutes. Average levels at each time point, peak level, and area under the curve (AUC) will be reported.
week 5-12 on the very low carbohydrate diet
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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)

  • 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:

    1. Standard MRI exclusion criteria
    2. Irregular menses
    3. Use of psychotropic medication other than SSRIs or other mild antidepressant or anxiety medications (unless these medications are safe to be held for several days to allow for the acquisition of MRI data).
Boston Children's Hospital logoBoston Children's Hospital
Study Responsible Party
Belinda Lennerz, Principal Investigator, Principal Investigator, Boston Children's Hospital
Study Central Contact
Contact: Belinda S Lennerz, MD, PhD, 8572183896, [email protected]
1 Study Locations in 1 Countries

Massachusetts

Boston Children's Hospital, Boston, Massachusetts, 02115, United States
Belinda S Lennerz, Contact, 857-218-3896, [email protected]
Recruiting