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Iron and Insulin Resistance in Overweight and Obese Humans (Fe)

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ClinicalTrials.gov Identifier: NCT03348020
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Jeffrey F Horowitz, University of Michigan

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.


Condition or disease Intervention/treatment Phase
Glucose Intolerance Insulin Resistance Iron Metabolism Procedure: Blood Donation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Iron Homeostasis, Adipose Tissue Lipolysis, and Insulin Resistance in Overweight and Obese Humans
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : January 30, 2023
Estimated Study Completion Date : January 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: Baseline Clinical Trial
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
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.

Experimental: Post-Blood Donation Clinical Trial
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
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.




Primary Outcome Measures :
  1. Change in Whole-body iron homeostasis [ Time Frame: 1 month ]

    The study team will measure:

    • Circulating ferritin, hepcidin, and soluble transferrin receptor concentrations in blood
    • Hemoglobin concentration and hematocrit
    • Circulating iron concentration, total iron binding capacity, and transferrin saturation in blood

  2. Change in markers of subcutaneous adipose tissue iron homeostasis and lipolytic regulation [ Time Frame: 1 month ]

    The study team will measure:

    • Adipose tissue non-heme iron content
    • mRNA and protein expression of key factors regulating iron homeostasis (e.g., ferritin, ferroportin, transferrin, transferrin receptor) and lipolysis (e.g., hormone-sensitive lipase, adipose triglyceride lipase)

  3. Change in Adipose tissue lipolysis [ Time Frame: 1 month ]
    Determined using a stable isotope infusion of [d5]glycerol

  4. Change in Peripheral insulin resistance [ Time Frame: 1 month ]
    Assessed as the steady-state glucose infusion rate during the last 20 min of a hyperinsulinemic-euglycemic clamp.

  5. Change in Adipose Tissue Insulin resistance [ Time Frame: 1 month ]
    Assessed as the insulin-induced suppression of lipolysis and non-esterified free fatty acid concentrations during the hyperinsulinemic-euglycemic clamp; also assessed as the adipose insulin resistance index (fasting insulin x fasting non-esterified fatty acid concentrations).


Secondary Outcome Measures :
  1. Change in Plasma substrates and hormone concentrations [ Time Frame: 1 month ]
    Plasma concentrations of triglyceride, fatty acid, glucose and insulin will be assessed using commercially available assays kits.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Subject Inclusion Criteria

  • 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

Subject Exclusion Criteria

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348020


Contacts
Contact: Suzette Howton 734-647-9850 smlstudies@umich.edu

Locations
United States, Michigan
Michigan Clincal Research Unit Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Suzette Howton, RDN    734-647-9850    suzetter@med.umich.edu   
Principal Investigator: Jeffrey F Horowitz, PhD         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Jeff Horowitz University of Michigan

Responsible Party: Jeffrey F Horowitz, Professor, Movement Science and Director, Substrate Metabolism Laboratory, University of Michigan
ClinicalTrials.gov Identifier: NCT03348020     History of Changes
Other Study ID Numbers: HUM00138926
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Overweight
Insulin Resistance
Glucose Intolerance
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperglycemia