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NCT Number: NCT06629688

Semaglutide and Intestinal Iron Absorption

Semaglutide belongs to a group of long-acting glucagon-like peptide 1 receptor agonists (GLP-1). Disorders in iron absorption have been linked to numerous medication, dietary, and nutrient interactions thus far. The study aimed to determine whether there is an effect of concomitant parenteral administration of semaglutide and oral iron preparations on iron absorption in patients with type 2 diabetes (T2DM).

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Iron Absorption Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital Dubrava

Zagreb, 10000, Croatia

About this study

Type 2 diabetes mellitus (T2DM) affects over 537 million people worldwide, making it a major chronic and progressive health problem among adults. Novel approaches to managing T2DM have been developed as a result of medical advancements. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are appealing options for the treatment of T2DM, since they efficiently reduce body weight and haemoglobin A1C with a minimal risk of hypoglycaemia.

Semaglutide, a long-acting GLP-1 RA, has a very high structural homology with endogenous GLP-1, high binding affinity to albumin, and resistance to degradation by the intestinal enzyme dipeptidyl peptidase-4. Because of these characteristics and his extended half-life, it can be used once weekly. Similar to all other GLP-1 RAs, semaglutide decreases gastrointestinal motility and slows stomach emptying. Delay in stomach emptying and intestinal motility can interfere with vitamin, mineral, and drug absorption. Iron is one of the essential micronutrients in the human body. On average, 10 - 20 mg of iron is consumed daily through food, but only 1 - 2 mg of iron is absorbed in the duodenum and the first section of the small intestine. It has been shown that drugs which decrease gastrointestinal motility can interfere with iron absorption. However, the relationship between parenteral semaglutide administration and intestine iron absorption has not been the subject of any prior studies. Thus, this study aimed to determine whether there is an effect of parenteral administration of semaglutide on iron absorption in patients with T2DM.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • T2DM patients
  • ages between 45 and 65
  • with poorly managed T2DM (HbA1c ≥ 7%)
  • who are candidates for treatment intensification and beginning of parenterally administered semaglutide

Exclusion criteria

  • hypersensitivity to GLP-1 RAs,
  • adequately controlled with current glucose-lowering medications,
  • already treated with GLP-1 RA,
  • type 1 diabetes mellitus or any other form of diabetes,
  • hemochromatosis,
  • iron deficiency anaemia,
  • sideropaenia,
  • severe chronic illnesses,
  • malignant neoplasms of any site,
  • chronic infectious diseases,
  • chronic rheumatic inflammatory diseases,
  • malabsorption syndrome,
  • inflammatory bowel disease,
  • history of gastrointestinal tract reduction surgery,
  • medications that interfere with absorption,
  • perimenopausal women

Treatment and study plan

semaglutide

Drug

Patient demographic and clinical data was collected and entered into a database made specifically for the study. The patients were examined, and their vital signs and body measures were recorded. Before the introduction of semaglutide therapy all participants completed an oral absorption iron test (OIAT). As described in previous studies, OIAT was conducted in an outpatient setting. Following the initial OIAT therapy with semaglutide was started. Each subject received parenterally administered one-weekly semaglutide. To enhance glycaemic control, the therapy was up-titrated every four weeks. Initially, the dose was set at 0.25 mg once a week, four weeks later, it was raised to 0.5 mg once weekly, and four weeks after that, it was increased to 1 mg once weekly. After reaching the maximum maintenance dosage of 1 mg for two weeks, each T2DM patient completed a follow-up OIAT at week 10 of the study. Data from the first and subsequent OIATs were analysed statistically.

Primary outcomes

  1. General objective

    Time frame: 10 weeks

    Number of T2DM participant that will have reduction in intestinal iron absorption after the semaglutide administration

Secondary outcomes

  1. Specific objectives

    Time frame: 10 weeks

    Correlation between serum ferritin levels prior to the OIAT and the degree of iron absorption during semaglutide administration in patients with T2DM.

Other outcomes

  1. Sex differences

    Time frame: 10 weeks

    Sex-dependent difference in intestinal iron absorption with the administration of semaglutide in patients with T2DM.

Sponsors and collaborators

Lead sponsor

University Hospital Dubrava

Other

Registry information

Official study title

The Effect of Parenterally Administred Semaglutide on Intestinal Iron Absorption in Individuals With Type 2 Diabetes Mellitus

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 8, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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