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

NCT04655131 | Completed

• 1 other identifier: 01-18-18
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of positive events for each protein amount.

  Events of postprandial hyperglycemia were defined as rise in glucose \>50 mg/dL compared to baseline

  from hour 0 to hour 5 after intervention

Study Arms (6)

Protein consumption : 0 gm

ACTIVE COMPARATOR

Participant's glucose levels are monitored from hour 0 to hour 5 after consumption of 0 gm of whey protein isolate

Dietary Supplement: Whey protein isolate

Protein consumption : 12.5 gm

EXPERIMENTAL

Participant's glucose levels are monitored from hour 0 to hour 5 after consumption of 12.5 gm of whey protein isolate

Dietary Supplement: Whey protein isolate

Protein consumption : 25 gm

EXPERIMENTAL

Participant's glucose levels are monitored from hour 0 to hour 5 after consumption of 25 gm of whey protein isolate

Dietary Supplement: Whey protein isolate

Protein consumption :37.5 gm

EXPERIMENTAL

Participant's glucose levels are monitored from hour 0 to hour 5 after consumption of 37.5 gm of whey protein isolate

Dietary Supplement: Whey protein isolate

Protein consumption : 50 gm

EXPERIMENTAL

Participant's glucose levels are monitored from hour 0 to hour 5 after consumption of 50 gm of whey protein isolate

Dietary Supplement: Whey protein isolate

Protein consumption : 62.5 gm

EXPERIMENTAL

Participant's glucose levels are monitored from hour 0 to hour 5 after consumption of 62.5 gm of whey protein isolate

Dietary Supplement: Whey protein isolate

Interventions

Whey protein isolate DIETARY_SUPPLEMENT

Commercially available, FDA approved whey protein isolate for dietary supplementation

Protein consumption : 0 gm; Protein consumption : 12.5 gm; Protein consumption : 25 gm; Protein consumption : 50 gm; Protein consumption : 62.5 gm; Protein consumption :37.5 gm

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Dalia Dalle, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary investigator

Study Record Dates

• First Submitted: November 22, 2020
• First Posted: December 7, 2020
• Study Start: June 18, 2018
• Primary Completion: November 25, 2018
• Study Completion: November 25, 2018
• Last Updated: December 7, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)