Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes

NCT06503809 | Recruiting DMC

• 1 other identifier: 202305041
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Type 1 diabetes; Ketogenic diet; Insulin sensitivity; Continuous glucose monitoring; Hypoglycemia

Outcome Measures

Primary Outcomes (2)

• Change in continuous glucose monitor (CGM) time-in-range

  Interstitial glucose percent time in range assessed by using a continuous glucose monitor

  Before and immediately after the dietary intervention

• Change in skeletal muscle insulin sensitivity

  Insulin sensitivity will be determined by the hyperinsulinemic-euglycemic clamp procedure

  Before and immediately after the dietary intervention

Secondary Outcomes (27)

• Change in daily insulin requirements

  Assessed before, during, and immediately after the dietary intervention

• Change in 24-hour glucose concentrations

  Before and immediately after the dietary intervention

• Change in 24-hour glucagon concentrations

  Before and immediately after the dietary intervention

• Change in whole-body palmitate turnover

  Before and immediately after the dietary intervention

• Change in plasma lipid profile

  Before and immediately after the dietary intervention

Study Arms (2)

Ketogenic Diet

EXPERIMENTAL

The Ketogenic Diet group will consume a very-low carbohydrate diet (\<50 g/day) diet. Participants will receive isocaloric packed-out meals for 12 weeks.

Behavioral: Ketogenic Diet

Standard Care

ACTIVE COMPARATOR

The Standard Care group will consume a diet consistent with the guidelines recommended by the American Diabetes Association that is high in non-starchy vegetables and lean protein sources and low in added sugar. Participants will receive isocaloric packed-out meals for 12 weeks.

Behavioral: Standard Diet

Interventions

Ketogenic Diet BEHAVIORAL

Participants will consume a very-low-carbohydrate ketogenic diet for 12 weeks.

Ketogenic Diet

Standard Diet BEHAVIORAL

Participants will consume an American Diabetes Association-recommended standard diet for 12 weeks.

Standard Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Insulin Resistance; Hypoglycemia

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Samuel Klein, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tara Wilmot, RDN

CONTACT

314-399-8576; tara.wilmot@wustl.edu

Max C Petersen, MD PhD

CONTACT

314-362-8450; max.p@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 16, 2024
• Study Start: August 12, 2024
• Primary Completion (Estimated): February 28, 2030
• Study Completion (Estimated): March 31, 2030
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

US (1)