Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes
ConditionDiabetes Mellitus, Type 1
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorWashington University School of Medicine
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Ketogenic Diet
BehavioralParticipants will consume a very-low-carbohydrate ketogenic diet for 12 weeks.
Standard Diet
BehavioralParticipants will consume an American Diabetes Association-recommended standard diet for 12 weeks.
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: Ketogenic DietExperimental treatment 1 intervention
Group B: Standard CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in continuous glucose monitor (CGM) time-in-range
Interstitial glucose percent time in range assessed by using a continuous glucose monitor
Time frame
Before and immediately after the dietary intervention2
Change in skeletal muscle insulin sensitivity
Insulin sensitivity will be determined by the hyperinsulinemic-euglycemic clamp procedure
Time frame
Before and immediately after the dietary interventionSecondary outcomes
1
Change in daily insulin requirements
The daily total dose of insulin used will be assessed
Time frame
Assessed before, during, and immediately after the dietary intervention2
Change in 24-hour glucose concentrations
Plasma glucose concentrations will be evaluated from frequent blood samples over a 24 hour period
Time frame
Before and immediately after the dietary intervention3
Change in 24-hour glucagon concentrations
Plasma glucagon concentrations will be evaluated from frequent blood samples over a 24 hour period
Time frame
Before and immediately after the dietary intervention4
Change in whole-body palmitate turnover
Palmitate turnover will be measured by isotope dilution
Time frame
Before and immediately after the dietary interventionSponsors and contacts
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Source ClinicalTrials.gov