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Effect of Protein Intake on Post Prandial Hyperglycemia in Children and Adolescents With Type1 Diabetes Mellitus

NCT04655131 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-12-07

No results posted yet for this study

Summary

In type 1 Diabetes Mellitus, patients receive insulin doses if they consume specific amounts of carbohydrates. Currently, insulin is not being administered for consumption of protein although studies in adults show that consuming about 75 grams of protein causes elevation in post prandial glucose levels and might need insulin coverage. We are proposing that this amount is different for kids and it might vary based on weight, age, pubertal stage, HbA1C or other factors.

This has not been studied in children before, and it will provide information about the amount of protein in the diet that can cause elevation in post prandial glucose.

Conditions

  • Diabetes Mellitus, Type 1
  • Hyperglycemia, Postprandial

Interventions

DIETARY_SUPPLEMENT

Whey protein isolate

Commercially available, FDA approved whey protein isolate for dietary supplementation

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Dalia Dalle, MD · University Hospitals Cleveland Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-18
Primary Completion
2018-11-25
Completion
2018-11-25

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04655131 on ClinicalTrials.gov