NCT03310203

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2018

Completed
Last Updated

January 11, 2019

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

October 11, 2017

Last Update Submit

January 10, 2019

Conditions

Iron Absorption

Outcome Measures

Primary Outcomes (2)

  • Iron absorption

    Labelled iron enrichment in red blood cells

    two weeks

  • Glycemic response

    oral glucose load

    2 hours

Secondary Outcomes (1)

  • Iron absorption

    2 hours

Study Arms (3)

Obese women: central obesity

EXPERIMENTAL

OGTT with iron

Diagnostic Test: Iron

Obese women: peripheral obesity

EXPERIMENTAL

OGTT with iron

Diagnostic Test: Iron

Lean women

EXPERIMENTAL

OGTT with iron

Diagnostic Test: Iron

Interventions

IronDIAGNOSTIC_TEST

Labelled iron

Also known as: OGTT
Lean womenObese women: central obesityObese women: peripheral obesity

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • pregnant women lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut

Beirut, Lebanon

Location

MeSH Terms

Interventions

Glucose Tolerance Test

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Officials

  • Omar Obeid, PhD

    American University of Beirut Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2017

First Posted

October 16, 2017

Study Start

September 27, 2017

Primary Completion

December 5, 2018

Study Completion

December 5, 2018

Last Updated

January 11, 2019

Record last verified: 2019-01

Locations

LE(1)