Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes
Purpose
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.
Condition
- Diabetes Mellitus, Type 1
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Ketogenic Diet |
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. |
|
|
Active Comparator Standard Care |
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. |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
St Louis, Missouri 63110
More Details
- NCT ID
- NCT06503809
- Status
- Recruiting
- Sponsor
- Washington University School of Medicine
Detailed Description
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.