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Diabetes Mellitus, Type 1NCT06503809

Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes

A study testing Ketogenic Diet and Standard Diet in people with Diabetes Mellitus, Type 1, run by Washington University School of Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Ketogenic Diet and Standard Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteUnited States
Study dates
12 Aug 2024to 31 Mar 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
Show all 20Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tara Wilmot, RDN contact

314-399-8576

tara.wilmot@wustl.edu

Max C Petersen, MD PhD contact

314-362-8450

max.p@wustl.edu

United States1 site, 1 recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Tara Wilmot, RDN, 314-399-8576, tara.wilmot@wustl.edu

    Max C Petersen, MD PhD, 314-362-8450, max.p@wustl.edu

    Recruiting

Other trials in United States

About this study

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 the 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.

Being tested
Ketogenic Diet, Standard Diet
Keywords
Type 1 diabetes, Ketogenic diet, Insulin sensitivity, Continuous glucose monitoring, Hypoglycemia
Medical subject headings
Diabetes Mellitus, Type 1, Insulin Resistance, Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ketogenic DietBehavioural

    Participants will consume a very-low-carbohydrate ketogenic diet for 12 weeks.

  • Standard DietBehavioural

    Participants will consume an American Diabetes Association-recommended standard diet for 12 weeks.

Study groups in NCT06503809
Study groupRoleWhat they receive
Ketogenic DietExperimentalThe Ketogenic Diet group will consume a very-low carbohydrate diet (<50 g/day) diet. Participants will receive isocaloric packed-out meals for 12 weeks.
Receives: Behavioral: Ketogenic Diet
Standard CareActive comparatorThe 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.
Receives: Behavioral: Standard Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in continuous glucose monitor (CGM) time-in-range

    Interstitial glucose percent time in range assessed by using a continuous glucose monitor

    Measured: Before and immediately after the dietary intervention

  2. Change in skeletal muscle insulin sensitivity

    Insulin sensitivity will be determined by the hyperinsulinemic-euglycemic clamp procedure

    Measured: Before and immediately after the dietary intervention

Secondary outcomes (27)

  1. Change in daily insulin requirements

    The daily total dose of insulin used will be assessed

    Measured: Assessed before, during, and immediately after the dietary intervention

  2. Change in 24-hour glucose concentrations

    Plasma glucose concentrations will be evaluated from frequent blood samples over a 24 hour period

    Measured: Before and immediately after the dietary intervention

  3. Change in 24-hour glucagon concentrations

    Plasma glucagon concentrations will be evaluated from frequent blood samples over a 24 hour period

    Measured: Before and immediately after the dietary intervention

  4. Change in whole-body palmitate turnover

    Palmitate turnover will be measured by isotope dilution

    Measured: Before and immediately after the dietary intervention

  5. Change in plasma lipid profile

    Fasting plasma lipid profile will be assessed

    Measured: Before and immediately after the dietary intervention

  6. Change in hepatic de novo lipogenesis

    Hepatic de novo lipogenesis will be assessed by the deuterated water method

    Measured: Before and immediately after the dietary intervention

  7. Change in de novo cholesterol synthesis

    Cholesterol synthesis will be assessed by the deuterated water method

    Measured: Before and immediately after the dietary intervention

  8. Change in fat mass

    Fat mass will be assessed using dual-energy x-ray absorptiometry (DXA)

    Measured: Before and immediately after the dietary intervention

  9. Change in fat-free mass

    Fat-free mass will be assessed using dual-energy x-ray absorptiometry (DXA)

    Measured: Before and immediately after the dietary intervention

  10. Change in intrahepatic triglyceride content

    Intrahepatic triglyceride content will be assessed by magnetic resonance imaging (MRI)

    Measured: Before and immediately after the dietary intervention

  11. Change in specific adipose tissue volumes

    Specific adipose tissue depot volumes will be assessed by magnetic resonance imaging (MRI)

    Measured: Before and immediately after the dietary intervention

  12. Change in plasma hs-CRP

    Plasma hs-CRP will be measured

    Measured: Before and immediately after the dietary intervention

  13. Change in plasma PAI-1

    Plasma PAI-1 will be measured

    Measured: Before and immediately after the dietary intervention

  14. Change in plasma IL-6

    Plasma IL-6 will be measured

    Measured: Before and immediately after the dietary intervention

  15. Change in plasma TNF-alpha

    Plasma TNF-alpha will be measured

    Measured: Before and immediately after the dietary intervention

  16. Change in plasma markers of liver function

    Plasma markers of liver function will be measured

    Measured: Before and immediately after the dietary intervention

  17. Change in plasma markers of kidney function

    Plasma markers of kidney function will be measured

    Measured: Before and immediately after the dietary intervention

  18. Change in plasma markers of bone turnover

    Plasma markers of bone turnover will be measured

    Measured: Before and immediately after the dietary intervention

  19. Change in percent time in hypoglycemia

    Percent time in hypoglycemia will be assessed by using a continuous glucose monitor

    Measured: Before and immediately after the dietary intervention

  20. Change in percent time in hyperglycemia

    Percent time in hyperglycemia will be assessed by using a continuous glucose monitor

    Measured: Before and immediately after the dietary intervention

  21. 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

    Measured: During the dietary intervention

  22. 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

    Measured: During the dietary intervention

  23. Change in bone mineral density

    Bone mineral density will be assessed using dual-energy x-ray absorptiometry (DXA)

    Measured: Before and immediately after the dietary intervention

  24. Change in sociobehavioral factors

    Sociobehavioral factors will be assessed by using validated questionnaires

    Measured: Before and immediately after the dietary intervention

  25. 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

    Measured: Immediately after the dietary intervention

  26. 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

    Measured: Immediately after the dietary intervention

  27. Change in glycated hemoglobin and albumin

    Glycated hemoglobin and albumin will be assessed

    Measured: Before, during, and immediately after the dietary intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2024
  2. Study start12 Aug 2024
  3. Primary completion28 Feb 2030 (estimated)
  4. Study completion31 Mar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06503809
Sponsor's protocol ID
202305041
Status last verified
Mar 2026
First submitted
27 Jun 2024
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Ketogenic Diet and Standard Diet in people with Diabetes Mellitus, Type 1, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tara Wilmot, RDN (314-399-8576, tara.wilmot@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in continuous glucose monitor (CGM) time-in-range (time frame: Before and immediately after the dietary intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06503809.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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