Effect of Taking a Single Tablet of Iron on Insulin Secretion

NCT05238987 | Completed

• 1 other identifier: IRB min.13294 Dt.26.08.2020
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Oral supplementation with highly bioavailable forms of iron, such as ferrous sulphate, is the treatment of choice for iron-deficiency anemia. Iron from ferrous sulphate is efficiently absorbed in the duodenum, resulting in a rapid increase in transferrin saturation and appearance of "free iron" or non-transferrin bound iron (NTBI) in blood. NTBI is highly reactive and can catalyze the generation of reactive oxygen species and cause oxidative tissue damage. Human pancreatic beta cells are known to express ZIP14, a transporter that has been implicated in uptake of NTBI from blood. In vitro and animal studies have shown that iron loading in beta cells can result in impaired insulin secretion. However, there are no human studies that have looked at the acute effects of oral iron intake on insulin secretion. In this study, we plan to look at the effect of a single oral dose of ferrous sulphate on insulin secretion kinetics in healthy individuals. A single arm before-and-after (pre-post) study design will be used. Consenting individuals who meet the participation criteria will undergo a 75g oral glucose tolerance test (OGTT) to document baseline insulin secretion kinetics. One week later, OGTT will be repeated after administering a single dose of ferrous sulphate (120 mg of elemental iron) 2 hours prior to the test. Iron-induced change in insulin secretion kinetics will be documented. In addition, we will determine changes in glucose tolerance, insulin resistance and insulin clearance rates.

Conditions

Insulin Secretion

Keywords

Oral iron; Insulin-Secreting Cells; Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Change in insulin secretion kinetics

  Change in insulin secretion rate as determined by deconvolution of C-peptide levels in blood during an oral glucose tolerance test based on a previously published mathematical model (Van Cauter et al., 1992).

  2 hours from intake of 120 mg of elemental iron

• Change in disposition index

  Disposition index is a measure of beta-cell function which is calculated as a product of insulin sensitivity and insulin secretion during an oral glucose tolerance test

  2 hours from intake of 120 mg of elemental iron

• Change in insulinogenic index

  A measure of beta-cell function which calculates the increase in insulin secretion in response to increase in glucose concentration during an oral glucose tolerance test

  2 hours from intake of 120 mg of elemental iron

Secondary Outcomes (3)

• Change in glucose tolerance

  2 hours from intake of 120 mg of elemental iron

• Change in insulin sensitivity

  2 hours from intake of 120 mg of elemental iron

• Change in insulin clearance rate

  2 hours from intake of 120 mg of elemental iron

Study Arms (1)

Healthy men (before-and-after (pre-post) study)

EXPERIMENTAL

Partcipants will undergo a 75g oral glucose tolerance test (OGTT) to document baseline insulin secretion kinetics. One week later, OGTT will be repeated after administering a single dose of ferrous sulphate (120 mg of elemental iron) 2 hours prior to the test.

Dietary Supplement: Ferrous sulphate

Interventions

Ferrous sulphate DIETARY_SUPPLEMENT

Single dose of ferrous sulphate (120 mg of elemental iron)

Healthy men (before-and-after (pre-post) study)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI - 18 to 30 kg/m\^2

You may not qualify if:

• Known case of diabetes mellitus/pre-diabetes
• History of chronic inflammatory disease
• Anemia (detection of pallor on examination). Absence of anemia will be confirmed by hemoglobin estimation done at the time of baseline OGTT based on WHO criteria.
• On iron supplementation
• History of any gastrointestinal disorders that might affect absorption of iron/glucose

Sponsors & Collaborators

• Christian Medical College, Vellore, India: lead

Study Sites (1)

Christian Medical College

Vellore, Tamil Nadu, 632002, India

Location

Related Publications (22)

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• Venkatesan P, Ramasamy J, Vanitha S, Jacob M, Varghese J. Impaired pancreatic beta-cell function after a single dose of oral iron: A before-and-after (pre-post) study. J Hum Nutr Diet. 2023 Jun;36(3):1111-1120. doi: 10.1111/jhn.13074. Epub 2022 Sep 7.

  PMID: 36000222 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Padmanaban Venkatesan, M.D.

  Christian Medical College, Vellore, India

  PRINCIPAL INVESTIGATOR

• Joe Varghese, M.D.,PhD

  Christian Medical College, Vellore, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Biochemistry

Model Details: Quasi-experimental single arm before-and-after (pre-post) study.

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: February 14, 2022
• Study Start: October 10, 2020
• Primary Completion: September 16, 2021
• Study Completion: September 16, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)