Microbiome Insulin Sensitivity Study

NCT03120871 | Completed

• 2 other identifiers: 16-2633UL1TR001082
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The Microbiome Insulin Sensitivity Study "MISS" is a pilot study designed to study microbiome composition across puberty and how it relates to insulin sensitivity and secretion in obese girls, who are at increased risk for developing type 2 diabetes in puberty. The investigators will evaluate the gut microbiome composition in fecal samples of 57 obese girls in three groups: prepubertal (Tanner 1), early pubertal (Tanner 2-3), and late pubertal (Tanner 4-5). Insulin sensitivity will also be measured via an intravenous glucose tolerance test (IVGTT) in 18 prepubertal and late pubertal participants.

Conditions

Obesity; Insulin Resistance; Type2 Diabetes

Keywords

Beta cell failure; Puberty; Microbiome; Insulin Sensitivity

Outcome Measures

Primary Outcomes (2)

• Firmicutes:Bacteroides ratio (F:B Ratio)

  F:B ratio in prepubertal, early pubertal, and late pubertal obese girls by high-throughput 16S ribosomal ribonucleic acid (16 S rRNA) sequencing from stool samples.

  Within 2 weeks of enrollment

• Insulin sensitivity (Si)

  Insulin sensitivity (Si) estimated from IV glucose tolerance testing using Bergman's minimal model

  Within 2 weeks of enrollment

Secondary Outcomes (3)

• Urinary estradiol metabolites (E1c)

  Within 2 weeks of enrollment

• Urinary luteinizing hormone (LH)

  Within 2 weeks of enrollment

• Urinary follicle stimulating hormone (FSH)

  Within 2 weeks of enrollment

Study Arms (1)

All subjects

Female sex, obese, aged 9-17 years, Tanner stages 1-5.

Eligibility Criteria

• Age: 9 Years - 17 Years
• Gender Eligibility Details: Participants must be biologically female
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

19 prepubertal (Tanner 1, \[T1\]), 19 early pubertal (T2-3), 19 late pubertal (T4-5) obese (BMI\>95%ile) females, age \>9 years.

You may qualify if:

• Female sex
• Obesity (BMI \> 95th percentile for age)
• Age \> 9 years, \<18 years

You may not qualify if:

• Medications affecting glucose metabolism
• Known T2D
• Known polycystic ovarian syndrome
• Known fatty liver disease (ALT \> 2x above the upper limit of normal)
• Chronic illness affecting glucose metabolism
• Antibiotic use in the previous 6 months

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institutes of Health (NIH): collaborator
• Children's Hospital Colorado: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool, urine, and serum and plasma will be collected and banked for future research.

MeSH Terms

Conditions

Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Megan M Kelsey, MD, MS

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 19, 2017
• Study Start: May 12, 2017
• Primary Completion: August 19, 2018
• Study Completion: August 19, 2018
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)