RECRUITING

Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes

Conditions

Diabetes Mellitus, Type 1 Type 1 diabetes Ketogenic diet Insulin sensitivity Continuous glucose monitoring Hypoglycemia

Quick Navigation

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 strong evidence that tight control of blood sugar reduces the risk of diabetes complications, most people with type 1 diabetes do not achieve recommended blood sugar targets. This randomized controlled trial will test whether a very-low- carbohydrate ketogenic diet can effectively and safely improve blood sugar control in adults with type 1 diabetes.

Official Title

Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes

Quick Facts

Study Start:2024-08-01

Study Completion:2029-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06503809

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 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age ≥18 and ≤65 years * T1D diagnosed \>1 year prior to screening * HbA1c 7.0%-9.0% * Stable insulin delivery method for the past 30 days * Ability to read all device instructions and insulin pump settings * eGFR ≥60 mL/min/1.73 m2 * Use of an insulin pump or insulin delivery by multiple daily injections * Use of personal CGM for at least 12 weeks and willing to change to Dexcom CGM for the duration of the study, if using a different sensor, to reduce variability in glucose values associated with different CGM products * Use of cellular phone with data capability for wireless connectivity to the CGM system.	* Body mass index \<20.0 or \>34.9 kg/m2 * Severe gastroparesis or history of bariatric surgery * Diabetes-related hospitalization (including for diabetic ketoacidosis or severe hypoglycemia) within 12 months of screening * Poorly controlled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg) * Taking diabetes medications, other than insulin (particularly SGLT2 inhibitors, which are associated with an increased risk of euglycemic DKA) * Structured exercise \>210 minutes per week * Pregnant, lactating, not using effective birth control if premenopausal, or planning to become pregnant within the 6-month study period * Unstable weight (\>4% change in the last 2 months) * Significant organ system dysfunction (e.g., severe pulmonary, renal, hepatic, or cardiovascular disease) * Anemia (Hgb \<10 g/dL) * Major psychiatric illness * Active tobacco use (\>8 cigarettes/day) or illegal drug use * Regular alcohol consumption (\>10 standard drinks per week) * Use of medications known to affect the study outcome measures or increase the risk of study procedures that cannot be temporarily discontinued for this study * Familial hypercholesterolemia * Active eating disorder * Dietary restrictions incompatible with a very-low-carbohydrate KD, vegan diet, vegetarian diet, severe lactose intolerance, severe aversion/sensitivity to eggs, fish, nuts, wheat, or soy, and any anaphylactic food allergy * Already consuming a low-carbohydrate (\<130 g/day) diet * Persons who are not able to grant voluntary informed consent * Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers an inappropriate candidate for the study.

Inclusion Criteria

Exclusion Criteria

* Age ≥18 and ≤65 years
* T1D diagnosed \>1 year prior to screening
* HbA1c 7.0%-9.0%
* Stable insulin delivery method for the past 30 days
* Ability to read all device instructions and insulin pump settings
* eGFR ≥60 mL/min/1.73 m2
* Use of an insulin pump or insulin delivery by multiple daily injections
* Use of personal CGM for at least 12 weeks and willing to change to Dexcom CGM for the duration of the study, if using a different sensor, to reduce variability in glucose values associated with different CGM products
* Use of cellular phone with data capability for wireless connectivity to the CGM system.

* Body mass index \<20.0 or \>34.9 kg/m2
* Severe gastroparesis or history of bariatric surgery
* Diabetes-related hospitalization (including for diabetic ketoacidosis or severe hypoglycemia) within 12 months of screening
* Poorly controlled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg)
* Taking diabetes medications, other than insulin (particularly SGLT2 inhibitors, which are associated with an increased risk of euglycemic DKA)
* Structured exercise \>210 minutes per week
* Pregnant, lactating, not using effective birth control if premenopausal, or planning to become pregnant within the 6-month study period
* Unstable weight (\>4% change in the last 2 months)
* Significant organ system dysfunction (e.g., severe pulmonary, renal, hepatic, or cardiovascular disease)
* Anemia (Hgb \<10 g/dL)
* Major psychiatric illness
* Active tobacco use (\>8 cigarettes/day) or illegal drug use
* Regular alcohol consumption (\>10 standard drinks per week)
* Use of medications known to affect the study outcome measures or increase the risk of study procedures that cannot be temporarily discontinued for this study
* Familial hypercholesterolemia
* Active eating disorder
* Dietary restrictions incompatible with a very-low-carbohydrate KD, vegan diet, vegetarian diet, severe lactose intolerance, severe aversion/sensitivity to eggs, fish, nuts, wheat, or soy, and any anaphylactic food allergy
* Already consuming a low-carbohydrate (\<130 g/day) diet
* Persons who are not able to grant voluntary informed consent
* Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers an inappropriate candidate for the study.

Contacts and Locations

Study Contact

Tara Wilmot, RDN

CONTACT

314-399-8576

tara.wilmot@wustl.edu

Max C Petersen, MD PhD

CONTACT

314-362-8450

max.p@wustl.edu

Principal Investigator

Samuel Klein, MD

PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Samuel Klein, MD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

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 Date2024-08-01

Study Completion Date2029-12-31

Study Record Updates

Study Start Date2024-08-01

Study Completion Date2029-12-31

Terms related to this study

Keywords Provided by Researchers

Type 1 diabetes
Ketogenic diet
Insulin sensitivity
Continuous glucose monitoring
Hypoglycemia

Additional Relevant MeSH Terms

Diabetes Mellitus, Type 1