Bisphenol A and Muscle Insulin Sensitivity

NCT03771066 | Completed DMC

• 1 other identifier: 2018-149-CP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study examine oral bisphenol A consumption on muscle insulin sensitivity and hepatic glucose suppression. Half of the participants will receive a diet plus BPA and the other half will receive a diet plus no bisphenol A.

Conditions

Insulin Sensitivity; Glucose Metabolism Disorders; Microtia

Keywords

bisphenol A; diet

Outcome Measures

Primary Outcomes (2)

• Change in rate of glucose disposal

  Three hour euglycemic hyperinsulinemic clamp technique with stable glucose isotope infusion to determine rate of glucose disposal

  Baseline and 4 days

• Change in rate of glucose appearance

  Ninety minutes stable glucose isotope infusion to determine rate of hepatic glucose appearance

  Baseline and 4 days

Secondary Outcomes (8)

• Change in concentration of insulin

  Baseline and 4 days

• Change in concentration of glucose

  Baseline and 4 days

• Change in concentration of c-peptide

  Baseline and 4 days

• Change in concentration of proinsulin

  Baseline and 4 days

• Change in concentration of adiponectin

  Baseline and 4 days

Study Arms (2)

Diet plus bisphenol A

EXPERIMENTAL

Participants will receive a 4-day diet plus bisphenol A at 50 ug/kg body weight.

Behavioral: bisphenol A

Placebo

PLACEBO COMPARATOR

Participants will receive a 4-day diet plus no bisphenol A.

Behavioral: Placebo

Interventions

bisphenol A BEHAVIORAL

Vanilla wafer cookie with bisphenol A administered

Diet plus bisphenol A

Placebo BEHAVIORAL

Vanilla wafer cookie with no bisphenol A

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• non-dieting
• sedentary (≤3 hour/week of aerobic exercise)
• normal-weight (BMI = 18.5 to 24.9 kg/m2)
• weight-stable for the previous 6 months
• free of any metabolic or chronic disease
• non-smoking, and sedentary

You may not qualify if:

• Hemoglobin A1C based on the American Diabetes Association guidelines of 5.7 to 6.4% (Prediabetes) or \>6.4% (Diabetes)
• impaired glucose tolerance
• type 1 diabetes
• type 2 diabetes
• colitis or any inflammatory bowel condition
• neurologic or psychiatric conditions
• smoking
• special diets (e.g. vegetarian, low-carbohydrate, Paleolithic, etc.)
• pregnant women or women trying to become pregnant

Sponsors & Collaborators

• California Polytechnic State University-San Luis Obispo: lead
• American Diabetes Association: collaborator

Study Sites (1)

California Polytechnic State University

San Luis Obispo, California, 93405, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Glucose Metabolism Disorders; Congenital Microtia

Interventions

bisphenol A

Condition Hierarchy (Ancestors)

Hyperinsulinism; Metabolic Diseases; Nutritional and Metabolic Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Todd Hagobian, PhD

  California Polytechnic State University-San Luis Obispo

  PRINCIPAL INVESTIGATOR

• Hannah Brunner-Gaydos

  California Polytechnic State University-San Luis Obispo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study will be a double-blinded study. Research staff collecting data and participants will not know treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This experimental study is a 2-group randomized, clinical trial comparing a 4-day energy balance diet plus oral BPA consumption at 50 ug/kg body weight (Diet+BPA) vs. 4-day energy balance diet plus oral placebo consumption (Diet+No BPA). Forty participants will be randomized to Diet+BPA and Diet+No BPA and will reside in a supervised environment at Cal Poly's sleep research facilities for 6 days (2-day baseline run-in, followed by 4-day treatment). Main outcome measures (muscle insulin sensitivity and hepatic glucose suppression) will be assessed at baseline and treatment periods.

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 10, 2018
• Study Start: January 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion, and will be available indefinitely.
• Access Criteria: Data access will be freely available for download on the Cal Poly Digital Commons website. Requestors will be required to sign a data access agreement.

Locations

US (1)