The Relation Between Adiposity, Inflammation, Glycaemia and Iron Absorption
Primary Purpose
Iron Absorption
Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Iron
Sponsored by

About this trial
This is an interventional basic science trial for Iron Absorption
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
- pregnant women lactating women
Sites / Locations
- American University of Beirut
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Obese women: central obesity
Obese women: peripheral obesity
Lean women
Arm Description
OGTT with iron
OGTT with iron
OGTT with iron
Outcomes
Primary Outcome Measures
Iron absorption
Labelled iron enrichment in red blood cells
Glycemic response
oral glucose load
Secondary Outcome Measures
Iron absorption
serum iron concentration
Full Information
NCT ID
NCT03310203
First Posted
October 11, 2017
Last Updated
January 10, 2019
Sponsor
American University of Beirut Medical Center
Collaborators
ETH Zurich (Switzerland)
1. Study Identification
Unique Protocol Identification Number
NCT03310203
Brief Title
The Relation Between Adiposity, Inflammation, Glycaemia and Iron Absorption
Official Title
The Relation Between Adiposity, Inflammation, Glycaemia and Iron Absorption: A Comparison Between Central and Peripheral Adiposity
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 27, 2017 (Actual)
Primary Completion Date
December 5, 2018 (Actual)
Study Completion Date
December 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American University of Beirut Medical Center
Collaborators
ETH Zurich (Switzerland)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A total of 126 premenopausal women (42 lean, 42 obese with central obesity, 42 obese with peripheral obesity) will be recruited. Anthropometric measurements and body composition using DEXA will be collected. Overnight fasted subjects will be asked to give baseline blood samples before consuming a meal containing 6 mg 57Fe in the form of FeSO4. Subjects will return after 14 days and a blood sample will be collected for measurement of isotopic enrichment into red blood cells, serving as well as a baseline for the OGTT. Subjects will then be asked to ingest a solution of glucose (50g) containing 100 mg of iron in the form of sodium ferrous citrate (SFC), after which blood samples will be collected 2 hours post iron and glucose load. All three blood samples collected at baseline, 2 weeks post labeled iron load, and 2 hours post glucose/iron load will be analyzed for their levels of iron, glycaemia and inflammatory parameters.
Detailed Description
Obese subjects with central and peripheral obesity
During the first phase, overweight/obese subjects with a BMI 28-35 Kg/m2 will be invited to a screening. At the screening, anthropometrics (weight, height, waist circumference) and body composition (using BIA and DEXA) will be measured. Based on the subject's distribution of body fat, those who have a predefined % body fat between 45-55% will be invited to join the study and they would fall into one of the following two groups:
42 subjects with >43% fat in the android sector (area from the pelvis to 20% of the distance between the pelvis and the neck cuts) according to the DEXA results (central adiposity) would be recruited
42 subjects with <43% fat in the android sector according to DEXA (peripheral adiposity) would be recruited.
Lean subjects At the same time, anthropometric (weight, height, waist circumference) and body composition (using BIA and DEXA) measurement will be conducted on interested lean subjects (BMI 20-25).
Overnight fasted subjects:
At T0:
There will be a determination of the type and degree of obesity through the measurement of weight, height, BMI, and WC, followed by both BIA screening and DEXA scan to obtain a more detailed image about the status of the participant.
At T1:
A fasting blood sample of 10 ml (4 ml EDTA coated tubes, 6 ml uncoated tubes) will be drawn to measure the inflammatory status, glycaemia, and iron levels of the participant by determining CRP, alpha-glycoprotein, hepcidin, ferritin, TfR, TIBC, HbA1c, insulin, FPG, serum iron, CBC and lipid profile.
After this blood test, the subject will be given a meal including 57Fe (6 mg iron as FeSO4).
At T2:
A second venous blood sample of 10 ml (4 ml EDTA coated tubes, 6 ml uncoated tubes) will be drawn for analysis of hemoglobin and erythrocyte isotopic composition as well as for the determination of serum ferritin, transferrin receptor, C-reactive protein, alpha-glycoprotein and hepcidin.
At T3:
A third venous blood sample of 10 ml (4 ml EDTA coated tubes, 6 ml uncoated tubes) will be drawn to measure the level of glucose, insulin, TG, FFA, TIBC and serum iron. This blood test will be an indicator of the level of glycaemia and iron appearance in the blood of the subject through the earlier ingestion of OGTT and oral iron load.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Absorption
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Obese women: central obesity
Arm Type
Experimental
Arm Description
OGTT with iron
Arm Title
Obese women: peripheral obesity
Arm Type
Experimental
Arm Description
OGTT with iron
Arm Title
Lean women
Arm Type
Experimental
Arm Description
OGTT with iron
Intervention Type
Diagnostic Test
Intervention Name(s)
Iron
Other Intervention Name(s)
OGTT
Intervention Description
Labelled iron
Primary Outcome Measure Information:
Title
Iron absorption
Description
Labelled iron enrichment in red blood cells
Time Frame
two weeks
Title
Glycemic response
Description
oral glucose load
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Iron absorption
Description
serum iron concentration
Time Frame
2 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
pregnant women lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Obeid, PhD
Organizational Affiliation
American University of Beirut Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
American University of Beirut
City
Beirut
Country
Lebanon
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Relation Between Adiposity, Inflammation, Glycaemia and Iron Absorption
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