Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2023-11-01
2024-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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T2DM subjects before and at week 10 of semaglutide therapy
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.
semaglutide
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.
Interventions
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semaglutide
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
65 Years
ALL
No
Sponsors
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University Hospital Dubrava
OTHER
Responsible Party
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Petra Meliš
Principal Investigator
Principal Investigators
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Srećko Marušić, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UH Dubrava
Locations
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University hospital Dubrava
Zagreb, , Croatia
Countries
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Other Identifiers
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sema-iron
Identifier Type: -
Identifier Source: org_study_id