Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes
NCT Number: NCT06503809
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus, Type 1
Interventions: BEHAVIORAL: Ketogenic Diet|BEHAVIORAL: Standard Diet
Sponsor: Washington University School of Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 58
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2029-12-31
Locations: Washington University School of Medicine, Saint Louis, Missouri, 63110, United States

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.

Primary Outcome Measures: 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 Outcome Measures: Change in daily insulin requirements, The daily total dose of insulin used will be assessed, Assessed before, during, and immediately after the dietary intervention|Change in 24-hour glucose concentrations, Plasma glucose concentrations will be evaluated from frequent blood samples over a 24 hour period, Before and immediately after the dietary intervention|Change in 24-hour glucagon concentrations, Plasma glucagon concentrations will be evaluated from frequent blood samples over a 24 hour period, Before and immediately after the dietary intervention|Change in whole-body palmitate turnover, Palmitate turnover will be measured by isotope dilution, Before and immediately after the dietary intervention|Change in plasma lipid profile, Fasting plasma lipid profile will be assessed, Before and immediately after the dietary intervention|Change in hepatic de novo lipogenesis, Hepatic de novo lipogenesis will be assessed by the deuterated water method, Before and immediately after the dietary intervention|Change in de novo cholesterol synthesis, Cholesterol synthesis will be assessed by the deuterated water method, Before and immediately after the dietary intervention|Change in fat mass, Fat mass will be assessed using dual-energy x-ray absorptiometry (DXA), Before and immediately after the dietary intervention|Change in fat-free mass, Fat-free mass will be assessed using dual-energy x-ray absorptiometry (DXA), Before and immediately after the dietary intervention|Change in intrahepatic triglyceride content, Intrahepatic triglyceride content will be assessed by magnetic resonance imaging (MRI), Before and immediately after the dietary intervention|Change in specific adipose tissue volumes, Specific adipose tissue depot volumes will be assessed by magnetic resonance imaging (MRI), Before and immediately after the dietary intervention|Change in plasma hs-CRP, Plasma hs-CRP will be measured, Before and immediately after the dietary intervention|Change in plasma PAI-1, Plasma PAI-1 will be measured, Before and immediately after the dietary intervention|Change in plasma IL-6, Plasma IL-6 will be measured, Before and immediately after the dietary intervention|Change in plasma TNF-alpha, Plasma TNF-alpha will be measured, Before and immediately after the dietary intervention|Change in plasma markers of liver function, Plasma markers of liver function will be measured, Before and immediately after the dietary intervention|Change in plasma markers of kidney function, Plasma markers of kidney function will be measured, Before and immediately after the dietary intervention|Change in plasma markers of bone turnover, Plasma markers of bone turnover will be measured, Before and immediately after the dietary intervention|Change in percent time in hypoglycemia, Percent time in hypoglycemia will be assessed by using a continuous glucose monitor, Before and immediately after the dietary intervention|Change in percent time in hyperglycemia, Percent time in hyperglycemia will be assessed by using a continuous glucose monitor, Before and immediately after the dietary intervention|Level 3 hypoglycemia event rate, Number of event rates for level 3 hypoglycemia defined as blood glucose or sensor glucose concentration \<54 mg/dL with neurological symptoms of low blood glucose concentration such as confusion, lethargy, seizure, or coma, During the 26-week dietary intervention|Diabetic ketoacidosis event rate, Number of diabetic ketoacidosis event rates defined as plasma beta-hydroxybutyrate concentration \>3 mmol/L, plasma bicarbonate concentration \< 18 mmol/L, pH\<7.30, and symptoms including polyuria, polydipsia, nausea, vomiting, or abdominal pain, During the 26-week dietary intervention|Change in bone mineral density, Bone mineral density will be assessed using dual-energy x-ray absorptiometry (DXA), Before and immediately after the dietary intervention|Change in sociobehavioral factors, Sociobehavioral factors will be assessed by using validated questionnaires, Before and immediately after the dietary intervention|Knowledge and perceptions of the diet, Dissemination and implementation (D\&I) survey measures available from the Washington University Center for Diabetes Translation Research D\&I Core will be used to assess participants' knowledge and perceptions of the diets at the end of the study, Immediately after the dietary intervention|Adaptations needed to implement the diet at the population level, Qualitative interviews will be performed to understand perceptions of the diet interventions and what adaptations might be needed to disseminate the intervention at a population level, Immediately after the dietary intervention