Incretin Hormones in Type 1 Diabetes Mellitus;Effect of Metformin Treatment
NCT ID: NCT04177303
Last Updated: 2020-02-18
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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UNKNOWN
PHASE3
44 participants
INTERVENTIONAL
2019-11-29
2022-11-29
Brief Summary
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Detailed Description
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Investigators' goal in the current protocol is to delineate the glucoregulatory role of incretin hormones in T1DM and the therapeutic advantages of adjunct metformin treatment over insulin monotherapy. In the absence of such knowledge, the development of effective strategies to improve metabolic homeostasis and ameliorate complications in T1DM patients will remain problematic. The central hypothesis of the study is that metformin, as an incretin-secretagogue, will enhance postprandial incretin secretion in T1DM patients, which will be reflected in reduced glucagon secretion and improvement in glycemic volatility. Mechanistic insight will be provided through changes in specific amino acids and metabolites patterns, chronic inflammation and the microbiome composition.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Metformin
Patients will continue with their standard insulin therapy and will additionally receive orally metformin 2gr/day.
Metformin
Participants will be randomized to metformin 2000 mg
Placebo
Patients will continue with their standard insulin therapy and will additionally receive placebo
Placebo
Participants will be randomized to placebo
Interventions
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Metformin
Participants will be randomized to metformin 2000 mg
Placebo
Participants will be randomized to placebo
Eligibility Criteria
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Inclusion Criteria
* T1DM (Diagnosis of diabetes before the age of 35 years and insulin use within 1 year of diagnosis)
* Treatment with multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII)
Exclusion Criteria
* NYHA stage 3 or 4 heart failure
* Uncontrolled angina
* Liver failure \[AST\>135 IU/L or ALT\>129IU/L (3 x the upper normal limit)\] • Kidney failure or GFR\<60 ml/min/1.73m2
* Gastrointestinal disease or gastroparesis
* Prior diagnosis of cancer within 2 years
* Other medication that affect glucose metabolism within the last 3 months (metformin, SGLT2, GLP-1 analogues, amylin analogues, systemic glucocorticosteroids)
* Untreated or uncontrolled thyroid disease
* Pregnancy or breastfeeding
* Alcohol consumption \> 2-drinks per day or other substance abuse
18 Years
ALL
No
Sponsors
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Hellenic Institute for the Study of Sepsis
OTHER
Responsible Party
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Principal Investigators
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Kotsa Kalliopi, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
1st Internal Medicine Department, AHEPA University Hospital
Locations
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Diabetes Center, 1st Internal Medicine Department, AHEPA University General Hospital of Thessaloniki
Thessaloniki, Thessaloniki, Greece
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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INCREDIBLE-ME
Identifier Type: -
Identifier Source: org_study_id
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