RECRUITING

Very Low Carbohydrate Diets and Glucagon Response in T1DM

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-01-03
Study Completion:2024-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04200391

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males and females with T1D for at least 1 year
  2. * Age 18 to 40 years
  3. * Tanner stage ≥ IV
  4. * BMI 18.5-35 kg/m2
  5. * Stable glycemic control (HbA1c 6.5-9%)
  6. * Use of a continuous glucose monitor (CGM)
  7. * Use of an insulin pump
  8. * Attendance of at least 1 diabetes care visit over the past 12 months (including virtual)
  1. * Ketoacidosis or severe hypoglycemia with seizure or coma in the past 6 months
  2. * Dietary restrictions or intolerances that are incompatible with the planned food deliveries, e.g. celiac disease, gastroparesis, certain food allergies
  3. * Following a weight-loss or otherwise restrictive diet
  4. * Vigorous exercise \>2 hours on \>3 days a week
  5. * History of an eating disorder or at risk for eating disorder, assessed by the Eating Disorders Diagnostic Scale (EDDS)
  6. * Major medical illness or use of medications other than insulin and metformin that could interfere with metabolic or glycemic variables
  7. * Significant psychiatric illness
  8. * Smoking, use of recreational drugs, or excessive alcohol consumption
  9. * Pregnancy or breastfeeding
  10. * Anemia
  11. * For participants who undergo MRI:
  12. 1. Standard MRI exclusion criteria
  13. 2. Irregular menses
  14. 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).

Contacts and Locations

Study Contact

Belinda S Lennerz, MD, PhD
CONTACT
8572183896
belinda.lennerz@childrens.harvard.edu
Svetlana Azova, MD
CONTACT
617-919-6675
svetlana.azova@childrens.harvard.edu

Principal Investigator

Belinda S Lennerz
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital

Study Locations (Sites)

Boston Children's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-03
Study Completion Date2024-07-31

Study Record Updates

Study Start Date2020-01-03
Study Completion Date2024-07-31

Terms related to this study

Keywords Provided by Researchers

  • nutrition
  • very low carbohydrate diet
  • ketogenic diet
  • nutritional ketosis
  • glucagon
  • hypoglycemia
  • glycogen
  • ketosis
  • ketones

Additional Relevant MeSH Terms

  • Type1diabetes