Iron and Insulin Resistance in Overweight and Obese Humans

NCT03348020 | Completed

• 1 other identifier: HUM00138926
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Determine the effects of reducing whole-body iron stores in overweight/obese subjects (via one-time blood donation) on adipose tissue iron content, factors regulating iron homeostasis and lipolytic rate in adipose tissue, as well as measures of adipose tissue and whole-body insulin resistance. After a screening visit to determine eligibility, subjects will undergo a battery of tests for the determination of primary outcome measures at baseline. They will then donate 1 unit (\~500 mL) of blood (at a local blood donation center) and return for a follow-up testing 4 weeks after blood donation. During the 4-week period between study trials, subjects will be required to maintain a stable body mass and not alter their dietary or physical activity habits.

Conditions

Glucose Intolerance; Insulin Resistance; Iron Metabolism

Outcome Measures

Primary Outcomes (1)

• Change in insulin sensitivity after blood donation

  A hyperinsulinemic-euglycemic clamp will be used to assess insulin sensitivity. The change in the glucose infusion rate will be used to measure the insulin sensitivity after blood donation.

  1 month

Secondary Outcomes (1)

• Change in lipolytic rate after blood donation

  1 month

Study Arms (2)

Baseline Clinical Trial

EXPERIMENTAL

Before blood donation, subjects will participate in a baseline clinical trial where the research team will perform a series of metabolic tests as described in the detailed study description.

Procedure: Blood Donation

Post-Blood Donation Clinical Trial

EXPERIMENTAL

1 month after blood donation, subjects will participate in post-blood donation clinical trial where the research team will perform a series of metabolic tests as described in the detailed study description.

Procedure: Blood Donation

Interventions

Blood Donation PROCEDURE

Subjects will donate blood within \~1 month after their baseline clinical trial. Subjects will report to the Substrate Metabolism Laboratory between 24 and 72 hours following blood donation. A finger-stick will be performed for the measurement of hemoglobin concentration.

Baseline Clinical Trial; Post-Blood Donation Clinical Trial

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-40
• (Body Mass Index ≥27 kg/m2\>27)
• Women must have regularly occurring menses and must be premenopausal
• Meet general blood donation eligibility requirements

You may not qualify if:

• Evidence/history of cardiovascular or metabolic disease
• Medications known to affect lipid or glucose metabolism, or inflammation
• Blood donation in the last 12 months
• Iron supplementation in the last 12 months (multivitamin with ≤100 %DV ok)
• Diagnosed anemia in the last 24 months
• Weight instability ≥ ±3kg in the last 6 months
• Women must not be pregnant or actively lactating

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Michigan Clincal Research Unit

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Glucose Intolerance; Insulin Resistance

Interventions

Blood Donation

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Tissue and Organ Procurement; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jeff Horowitz

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Movement Science and Director, Substrate Metabolism Laboratory

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 20, 2017
• Study Start: September 1, 2018
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)