Clinical trial NCT06629688: Semaglutide and Intestinal Iron Absorption
Official title: The Effect of Parenterally Administred Semaglutide on Intestinal Iron Absorption in Individuals With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2
Iron Absorption
Keywords: type 2 diabetes mellitus
semaglutide
iron
oral iron absorption test
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 51
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients between the ages of 45 and 65 with poorly controlled T2DM (HbA1c ≥ 7%) who were candidates for treatment intensification and beginning of parenterally administered semaglutide were eligible to participate in the study.
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: General objective
timeFrame: 10 weeks
Secondary outcomes:
measure: Specific objectives
timeFrame: 10 weeks
Other outcomes:
measure: Sex differences
timeFrame: 10 weeks
Locations:
city: Zagreb
country: Croatia
facility: University hospital Dubrava
Study officials:
affiliation: UH Dubrava
name: Srećko Marušić, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: