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
Qualifiers
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
Treatments tested in this trial
- Ketogenic Diet
- Standard Diet
Treatment groups
58 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov