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ketogenic diet for Type 1 Diabetes

Q: Are people who have reached their second decade of life considered suitable candidates for participation in this study?

The study's eligibility parameters require participants to be between 5 and 12 years of age.

Q: Which specific criteria determine the eligibility of individuals to participate in this research study?

To qualify for participation, individuals must be diagnosed with <a href="https://www.withpower.com/clinical-trials/type-1-diabetes">type 1 diabetes</a> and fall between the ages of five and twelve. This investigation aims to enroll approximately 52 eligible participants.

Q: What is the upper limit of participant enrollment for this medical study?

Yes, the details on clinicaltrials.gov indicate that this research is actively seeking participants. The trial was initially listed on April 1st, 2024 and last revised on May 2nd, 2024. Approximately 52 individuals are being sought from a single site for enrollment in the study.

Q: Is the recruitment phase still ongoing for participants in this medical study?

Indeed, details available on clinicaltrials.gov confirm the ongoing recruitment for this trial. The study was initially published on April 1st, 2024, and recently revised on May 2nd, 2024. There is an opportunity for enrollment of up to 52 participants at a single site.

N/A

Recruiting

Led By Belinda Lennerz

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children aged 5 to 12 years

Type 1 diabetes confirmed by immediate insulin requirement with autoimmunity markers (≥2 positive antibodies [glutamate decarboxylase-65, islet-antigen-2, zinc transporter-8, insulin [prior to first insulin dose])

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 3, 5, 7, 9, and 24 months

Awards & highlights

Study Summary

This trial will study the effects of a ketogenic diet on children newly diagnosed with type 1 diabetes. The trial aims to determine if the diet can help delay the progression of diabetes, improve diabetes control,

Who is the study for?

This trial is for children aged 5-12 with newly diagnosed type 1 diabetes, confirmed by insulin requirement and autoimmunity markers. The family must be committed to participating in the study's education and dietary intervention.Check my eligibility

What is being tested?

The trial tests if a ketogenic diet can extend the 'honeymoon' period of type 1 diabetes, improve control over it, and assess its safety and sustainability. It involves free meals, supplements, education, regular check-ins, blood sample collection after a test meal, stool samples for microbiome analysis.See study design

What are the potential side effects?

Potential side effects may include changes in digestion due to the ketogenic diet such as constipation or diarrhea. Blood draws might cause discomfort or bruising. Long-term effects on growth or nutrition will also be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is between 5 and 12 years old.

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I was diagnosed with Type 1 diabetes and needed insulin immediately, confirmed by positive autoimmunity markers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 3, 5, 7, 9, and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 3, 5, 7, 9, and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, 5, 7, 9, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Decline in Beta-cell Function

Secondary outcome measures

Average Blood Glucose

BMI

Child Eating Disorder Examination Questionnaire (ChEDE-Q8)

+26 more

Other outcome measures

BOHB (beta-hydroxybutyrate), fasting blood concentration

Confirmed Ketoacidosis

Diabetes Related Emergency Visits

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ketogenic dietExperimental Treatment1 Intervention

The diet will be high in protein and healthy fats and comprise meat, fish, fibrous vegetables, nuts, dairy, and berries. Macronutrient composition will be ~ 5% carbohydrate, 20% protein, 70% fat. Participants will receive a daily multi-vitamin, magnesium supplement, and supplemental salt (bouillon cubes) to ascertain micronutrient sufficiency and help with transition to the diet.

Group II: standard dietActive Control1 Intervention

The diet will be consistent with prevailing dietary guidelines and recommendations and contain meat, fish, grains, vegetables, fruit and dairy. At least 50% of grain-based products will be whole grains. Meats will be primarily lean, and dairy products will be fat-free or low-fat. Macronutrient composition will be ~50% carbohydrate (<10% added sugars), 20% protein, 30% fat. Participants will receive a daily multi-vitamin supplement to ascertain micronutrient sufficiency.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

766 Previous Clinical Trials

5,580,737 Total Patients Enrolled

University of South FloridaOTHER

414 Previous Clinical Trials

188,245 Total Patients Enrolled

Indiana UniversityOTHER

992 Previous Clinical Trials

1,095,233 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people who have reached their second decade of life considered suitable candidates for participation in this study?

"The study's eligibility parameters require participants to be between 5 and 12 years of age."

Answered by AI

Which specific criteria determine the eligibility of individuals to participate in this research study?

"To qualify for participation, individuals must be diagnosed with type 1 diabetes and fall between the ages of five and twelve. This investigation aims to enroll approximately 52 eligible participants."

Answered by AI

What is the upper limit of participant enrollment for this medical study?

"Yes, the details on clinicaltrials.gov indicate that this research is actively seeking participants. The trial was initially listed on April 1st, 2024 and last revised on May 2nd, 2024. Approximately 52 individuals are being sought from a single site for enrollment in the study."

Answered by AI

Is the recruitment phase still ongoing for participants in this medical study?

"Indeed, details available on clinicaltrials.gov confirm the ongoing recruitment for this trial. The study was initially published on April 1st, 2024, and recently revised on May 2nd, 2024. There is an opportunity for enrollment of up to 52 participants at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Carbohydrate Beta Cell Function and Glucose Control in Children With Diabetes

Belinda Lennerz 2024. "Carbohydrate Beta Cell Function and Glucose Control in Children With Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05899166.

All > Gestational Diabetes > Type 1 Diabetes