Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes
ID: NCT06503809
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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.
Read Full Scientific Objectives & Methods
A very-low-carbohydrate ketogenic diet (≤50 g carbohydrate/day) could reduce glycemic variability, total daily insulin requirement, and HbA1c in people with type 1 diabetes (T1D). Indeed, several case series and observational studies of using a ketogenic diet (KD) in people with T1D have observed such benefits. However, no randomized controlled trials (RCTs) have evaluated the efficacy of KD for \>7 days in people with T1D. In addition, there are serious concerns regarding the safety and tolerability of a KD in patients with T1D, including the potential for an increased risk of hypoglycemia, diabetic ketoacidosis, dyslipidemia, insulin resistance, decreased bone mineral density, and impaired quality of life. This study is a 12-week RCT to evaluate the clinical efficacy, metabolic function, safety, socio-behavioral impact, acceptability and potential for dissemination of an isocaloric KD compared with an American Diabetes Association-recommended control diet in adults with T1D.
Participants will consume a very-low-carbohydrate ketogenic diet for 12 weeks.
Participants will consume an American Diabetes Association-recommended standard diet for 12 weeks.
Treatment Arms Description
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.
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.
- 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.
- 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 tobacco use (\>8 cigarettes/day) or illegal drug use
- Regular alcohol consumption (\>10 standard drinks per week)
- Use of medications known to affect the study outcome measures or increase the risk of study procedures that cannot be temporarily discontinued for this study
- Familial hypercholesterolemia
- Active eating disorder
- Dietary restrictions incompatible with a very-low-carbohydrate KD, vegan diet, vegetarian diet, severe lactose intolerance, severe aversion/sensitivity to eggs, fish, nuts, wheat, or soy, and any anaphylactic food allergy
- Already consuming a low-carbohydrate (\<130 g/day) diet
- Persons who are not able to grant voluntary informed consent
- Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers an inappropriate candidate for the study.
Primary Outcome Measures
- Change in continuous glucose monitor (CGM) time-in-range — Time Frame: Before and immediately after the dietary intervention
Interstitial glucose percent time in range assessed by using a continuous glucose monitor
- Change in skeletal muscle insulin sensitivity — Time Frame: Before and immediately after the dietary intervention
Insulin sensitivity will be determined by the hyperinsulinemic-euglycemic clamp procedure
View Secondary Outcome Measures (27)
- Change in daily insulin requirements — Time Frame: Assessed before, during, and immediately after the dietary intervention
The daily total dose of insulin used will be assessed
- Change in 24-hour glucose concentrations — Time Frame: Before and immediately after the dietary intervention
Plasma glucose concentrations will be evaluated from frequent blood samples over a 24 hour period
- Change in 24-hour glucagon concentrations — Time Frame: Before and immediately after the dietary intervention
Plasma glucagon concentrations will be evaluated from frequent blood samples over a 24 hour period
- Change in whole-body palmitate turnover — Time Frame: Before and immediately after the dietary intervention
Palmitate turnover will be measured by isotope dilution
- Change in plasma lipid profile — Time Frame: Before and immediately after the dietary intervention
Fasting plasma lipid profile will be assessed
- Change in hepatic de novo lipogenesis — Time Frame: Before and immediately after the dietary intervention
Hepatic de novo lipogenesis will be assessed by the deuterated water method
- Change in de novo cholesterol synthesis — Time Frame: Before and immediately after the dietary intervention
Cholesterol synthesis will be assessed by the deuterated water method
- Change in fat mass — Time Frame: Before and immediately after the dietary intervention
Fat mass will be assessed using dual-energy x-ray absorptiometry (DXA)
- Change in fat-free mass — Time Frame: Before and immediately after the dietary intervention
Fat-free mass will be assessed using dual-energy x-ray absorptiometry (DXA)
- Change in intrahepatic triglyceride content — Time Frame: Before and immediately after the dietary intervention
Intrahepatic triglyceride content will be assessed by magnetic resonance imaging (MRI)
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
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View Official Medical/Scientific Title
Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes