An interventional study of Ketogenic Diet and Standard Diet in Diabetes Mellitus, Type 1, sponsored by Washington University School of Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
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.
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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 58 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Ketogenic Diet
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.
Behavioral: Standard Diet
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.
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 intervention
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 intervention
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 intervention
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 intervention
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 intervention
Change in whole-body palmitate turnover
Palmitate turnover will be measured by isotope dilution
Time frame: Before and immediately after the dietary intervention
Change in plasma lipid profile
Fasting plasma lipid profile will be assessed
Time frame: 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
Time frame: Before and immediately after the dietary intervention
Change in de novo cholesterol synthesis
Cholesterol synthesis will be assessed by the deuterated water method
Time frame: Before and immediately after the dietary intervention
Change in fat mass
Fat mass will be assessed using dual-energy x-ray absorptiometry (DXA)
Time frame: 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)
Time frame: Before and immediately after the dietary intervention
Change in intrahepatic triglyceride content
Intrahepatic triglyceride content will be assessed by magnetic resonance imaging (MRI)
Time frame: 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)
Time frame: Before and immediately after the dietary intervention
Change in plasma hs-CRP
Plasma hs-CRP will be measured
Time frame: Before and immediately after the dietary intervention
Change in plasma PAI-1
Plasma PAI-1 will be measured
Time frame: Before and immediately after the dietary intervention
Change in plasma IL-6
Plasma IL-6 will be measured
Time frame: Before and immediately after the dietary intervention
Change in plasma TNF-alpha
Plasma TNF-alpha will be measured
Time frame: Before and immediately after the dietary intervention
Change in plasma markers of liver function
Plasma markers of liver function will be measured
Time frame: Before and immediately after the dietary intervention
Change in plasma markers of kidney function
Plasma markers of kidney function will be measured
Time frame: Before and immediately after the dietary intervention
Change in plasma markers of bone turnover
Plasma markers of bone turnover will be measured
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: During the 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
Time frame: During the dietary intervention
Change in bone mineral density
Bone mineral density will be assessed using dual-energy x-ray absorptiometry (DXA)
Time frame: Before and immediately after the dietary intervention
Change in sociobehavioral factors
Sociobehavioral factors will be assessed by using validated questionnaires
Time frame: 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
Time frame: 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
Time frame: Immediately after the dietary intervention
Change in glycated hemoglobin and albumin
Glycated hemoglobin and albumin will be assessed
Time frame: Before, during, and immediately after the dietary intervention
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