Semaglutide and Intestinal Iron Absorption

NCT06629688 | Completed

• 1 other identifier: sema-iron
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes Mellitus Type 2; Iron Absorption

Keywords

type 2 diabetes mellitus; semaglutide; iron; oral iron absorption test

Outcome Measures

Primary Outcomes (1)

• General objective

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

  10 weeks

Secondary Outcomes (1)

• Specific objectives

  10 weeks

Other Outcomes (1)

• Sex differences

  10 weeks

Study Arms (1)

T2DM subjects before and at week 10 of semaglutide therapy

EXPERIMENTAL

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.

Drug: semaglutide

Interventions

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.

T2DM subjects before and at week 10 of semaglutide therapy

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• University Hospital Dubrava: lead

Study Sites (1)

University hospital Dubrava

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

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

Study Officials

• Srećko Marušić, MD, PhD

  UH Dubrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 8, 2024
• Study Start: November 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

CR (1)