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

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 1, Hyperglycemia, Postprandial

In brief

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.

Key facts

Study ID

NCT04655131

Run by

University Hospitals Cleveland Medical Center

People needed

11

Starts

2018-06-18

Expected to finish

2018-11-25

Last updated by the study team

2020-12-07

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• . Duration of type 1 diabetes for > 1year.
• On insulin pump or multiple daily injection regimen
• Uses a personal Dexcom CGM
• Age: 5- 17 years
• HbA1C range: < 9%

You may not qualify if…

• Hyperlipidemia
• Diabetic gastroparesis
• Dietary restrictions
• Celiac disease and other malabsorption syndromes
• Uncontrolled hypothyroidism
• Chronic use of steroids or antipsychotics
• Metabolic disorders of gluconeogenesis
• Use of oral hypoglycemic agents
• Participating in another clinical trial

Where it is running

• University Hospitals Cleveland medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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