Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
United States
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Contact Information
Primary
Tara Wilmot, RDN
tara.wilmot@wustl.edu
314-399-8576
Backup
Max C Petersen, MD PhD
max.p@wustl.edu
314-362-8450
Time Frame
Start Date: 2024-08-12
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 58
Treatments
Experimental: Ketogenic Diet
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.
Active_comparator: Standard Care
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.
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine

This content was sourced from clinicaltrials.gov