Glucose IntoleranceFeNCT03348020
Iron and Insulin Resistance in Overweight and Obese Humans
A study testing Blood Donation in people with Glucose Intolerance and Insulin Resistance, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Intolerance, Insulin Resistance, Iron Metabolism
- What is being tested?
- Blood Donation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Clincal Research Unit
Ann Arbor, Michigan, 48109
About this study
Official title: Iron Homeostasis, Adipose Tissue Lipolysis, and Insulin Resistance in Overweight and Obese Humans
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.
Read the detailed description
Screening:
If a potential subject meets the eligibility criteria after completing the general pre-screening questionnaire, they will be contacted to set up an in-person screening visit where the comprehensive written informed consent will be obtained. This visit may occur either at the Michigan Clinical Research Unit (MCRU) or at the Substrate Metabolism Laboratory (SML). Subjects will complete health history, food frequency, and physical activity questionnaires. Subjects that meet eligibility requirements and provide written informed consent will have a finger-stick performed for the assessment of hemoglobin concentration. Women with hemoglobin < 13.0 g/dL and men with hemoglobin < 14.0 g/dL will be withdrawn from the study.
Percent body fat will be measured using Dual Energy X-ray Absorptiometry [DEXA]. Women will provide a urine sample for a urine pregnancy test prior to the DEXA scan; if a subject has a positive pregnancy test prior to the DEXA scan, they will be withdrawn. The DEXA body composition assessment test may be performed at the screening visit or scheduled anytime between the screening visit and the baseline trial.
Baseline Trial:
Subjects will be provided general instructions on what to eat in the 3 days leading up to their baseline trial and be required to abstain from planned exercise in the 3 days leading up to the baseline and post-blood donation study trials. They will record their dietary intake during the 3 days leading up to the baseline trial and replicate it during the 3 days prior to the post-blood donation study trial. They will be required to fast the night before the trials starting at 9:00PM.
Subjects will arrive at MCRU at ~07:00AM. After measurement of body weight and resting blood pressure, intravenous catheters (IV) will be placed in each arm (one for blood sampling and the other for infusion).
At ~7:50 AM blood samples (in 5 minute intervals) will be collected. A ~8:00 AM a tracer-labeled glycerol infusion will begin. The tracer-labeled glycerol infusion that is infused occurs naturally in the body. By injecting a slightly greater amount of this substance than is already in the body, the rate of fat breakdown and fat burning is able to be measured. One of the subject's hands will be placed within a "hot-hand box" to enable the study team to collect arterialized venous blood samples from the intravenous catheter. At ~08:30AM, a small sample of abdominal fat tissue will be collected. Between ~09:50 and 10:00, three blood samples will be collected to determine basal lipolysis. At ~10:00, we will start the hyperinsulinemic, euglycemic clamp procedure to measure the body's sensitivity to insulin. During this procedure insulin and glucose will be infused through the IV in the forearm and blood samples will be collected periodically to monitor the subjects blood sugar. The infusion rate of glucose will be changed accordingly to ensure that the subjects blood sugar is maintained at a healthy/normal level. This procedure will take about two hours. Following completion, The insulin will be discontinued and the subject will be provided a lunch and the glucose will be gradually tapered off over the next hour. The study team will ensure the subjects blood glucose levels are stable prior to discharge.
Blood Donation:
Subjects will donate blood within ~1 month after their baseline 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.
Post-Blood Donation Trial:
The exact same procedures as performed in the Baseline Trial will be repeated 4 weeks after the subject's blood donation.
Diet/Physical Activity/Weight Maintenance:
Subjects will be required to maintain their normal diet and physical activity habits during the study. Following the baseline trial, subjects will be provided with a scale and asked to weigh themselves at home on a daily basis. If body weight changes ±2kg from their initial weight, subjects will consult with our research dietitian for strategies to maintain weight during the period between study trials.
- Conditions
- Glucose Intolerance, Insulin Resistance, Iron Metabolism
- Being tested
- Blood Donation
- Medical subject headings
- Glucose Intolerance, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DonationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Blood Donation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (1)
Change in lipolytic rate after blood donation
rate of appearance of glycerol
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 Sep 2018
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose IntoleranceStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey F Horowitz, University of Michigan
- Investigators
- Jeff Horowitz, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348020
- Sponsor's protocol ID
- HUM00138926
- Acronym
- Fe
- Status last verified
- Mar 2022
- First submitted
- 15 Nov 2017
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Homeostasis, Adipose Tissue Lipolysis, and Insulin Resistance in Overweight and Obese Humans
- ClinicalTrials.gov ID
- NCT03348020
- Acronym / sponsor ID
- Fe / HUM00138926
- Conditions
- Glucose Intolerance, Insulin Resistance, Iron Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Screening:
If a potential subject meets the eligibility criteria after completing the general pre-screening questionnaire, they will be contacted to set up an in-person screening visit where the comprehensive written informed consent will be obtained. This visit may occur either at the Michigan Clinical Research Unit (MCRU) or at the Substrate Metabolism Laboratory (SML). Subjects will complete health history, food frequency, and physical activity questionnaires. Subjects that meet eligibility requirements and provide written informed consent will have a finger-stick performed for the assessment of hemoglobin concentration. Women with hemoglobin < 13.0 g/dL and men with hemoglobin < 14.0 g/dL will be withdrawn from the study.
Percent body fat will be measured using Dual Energy X-ray Absorptiometry [DEXA]. Women will provide a urine sample for a urine pregnancy test prior to the DEXA scan; if a subject has a positive pregnancy test prior to the DEXA scan, they will be withdrawn. The DEXA body composition assessment test may be performed at the screening visit or scheduled anytime between the screening visit and the baseline trial.
Baseline Trial:
Subjects will be provided general instructions on what to eat in the 3 days leading up to their baseline trial and be required to abstain from planned exercise in the 3 days leading up to the baseline and post-blood donation study trials. They will record their dietary intake during the 3 days leading up to the baseline trial and replicate it during the 3 days prior to the post-blood donation study trial. They will be required to fast the night before the trials starting at 9:00PM.
Subjects will arrive at MCRU at ~07:00AM. After measurement of body weight and resting blood pressure, intravenous catheters (IV) will be placed in each arm (one for blood sampling and the other for infusion).
At ~7:50 AM blood samples (in 5 minute intervals) will be collected. A ~8:00 AM a tracer-labeled glycerol infusion will begin. The tracer-labeled glycerol infusion that is infused occurs naturally in the body. By injecting a slightly greater amount of this substance than is already in the body, the rate of fat breakdown and fat burning is able to be measured. One of the subject's hands will be placed within a "hot-hand box" to enable the study team to collect arterialized venous blood samples from the intravenous catheter. At ~08:30AM, a small sample of abdominal fat tissue will be collected. Between ~09:50 and 10:00, three blood samples will be collected to determine basal lipolysis. At ~10:00, we will start the hyperinsulinemic, euglycemic clamp procedure to measure the body's sensitivity to insulin. During this procedure insulin and glucose will be infused through the IV in the forearm and blood samples will be collected periodically to monitor the subjects blood sugar. The infusion rate of glucose will be changed accordingly to ensure that the subjects blood sugar is maintained at a healthy/normal level. This procedure will take about two hours. Following completion, The insulin will be discontinued and the subject will be provided a lunch and the glucose will be gradually tapered off over the next hour. The study team will ensure the subjects blood glucose levels are stable prior to discharge.
Blood Donation:
Subjects will donate blood within ~1 month after their baseline 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.
Post-Blood Donation Trial:
The exact same procedures as performed in the Baseline Trial will be repeated 4 weeks after the subject's blood donation.
Diet/Physical Activity/Weight Maintenance:
Subjects will be required to maintain their normal diet and physical activity habits during the study. Following the baseline trial, subjects will be provided with a scale and asked to weigh themselves at home on a daily basis. If body weight changes ±2kg from their initial weight, subjects will consult with our research dietitian for strategies to maintain weight during the period between study trials.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline Clinical Trial | Experimental | Procedure: Blood DonationBefore 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. |
| Post-Blood Donation Clinical Trial | Experimental | Procedure: Blood Donation1 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DonationSubjects 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. | Procedure or surgery | Baseline Clinical Trial, Post-Blood Donation Clinical Trial |
Primary outcome
Change in insulin sensitivity after blood donation
Time frame: 1 month
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 secondary outcome
Change in lipolytic rate after blood donation
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Horowitz principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Donation in people with Glucose Intolerance and Insulin Resistance, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in insulin sensitivity after blood donation (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.