The Relation Between Adiposity, Inflammation, Glycaemia and Iron Absorption

The Relation Between Adiposity, Inflammation, Glycaemia and Iron Absorption: A Comparison Between Central and Peripheral Adiposity

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.

Study Overview

• Status: Completed
• Conditions: Iron Absorption
• Intervention / Treatment: Diagnostic test: Iron

Detailed Description

1. 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.
2. 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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • American University of Beirut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

-

Exclusion Criteria:

• pregnant women lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Obese women: central obesity; OGTT with iron	Diagnostic test: Iron; Labelled iron; Other Names: OGTT
EXPERIMENTAL: Obese women: peripheral obesity; OGTT with iron	Diagnostic test: Iron; Labelled iron; Other Names: OGTT
EXPERIMENTAL: Lean women; OGTT with iron	Diagnostic test: Iron; Labelled iron; Other Names: OGTT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Iron absorption	Labelled iron enrichment in red blood cells	two weeks
Glycemic response	oral glucose load	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Iron absorption	serum iron concentration	2 hours

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Collaborators: ETH Zurich (Switzerland)

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 27, 2017
• Primary Completion (ACTUAL): December 5, 2018
• Study Completion (ACTUAL): December 5, 2018

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: October 13, 2017
• First Posted (ACTUAL): October 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Inflammation
• Other Study ID Numbers: NUT:OO:23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No