Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes (NCT06503809) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes
United States58 participantsStarted 2024-08-12
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
Exclusion Criteria:
* 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 to…
What they're measuring
1
Change in continuous glucose monitor (CGM) time-in-range
Timeframe: Before and immediately after the dietary intervention
2
Change in skeletal muscle insulin sensitivity
Timeframe: Before and immediately after the dietary intervention