??CRETIN HORMONES AND THE ROLE OF METFORMIN IN THE TREATMENT OF TYPE 1 DIABETES MELLITUS

Phase 1

• Conditions: GUT-DERIVED INCRETIN HORMONES IN THE PATHOPHYSIOLOGY OF TYPE 1 DIABETES MELLITUS; EFFECT OF METFORMIN TREATMENT; MedDRA version: 20.0 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2018-003022-89-GR
• Lead Sponsor: HELLENIC INSTITUTE FOR THE STUDY OF SEPSIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-02
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 44

Inclusion Criteria

•Age = 18 years
•T1DM (Diagnosis of diabetes before the age of 35 years and insulin use within 1 year from diagnosis)
•Treatment with multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

Exclusion Criteria

•Acute or within the last 3 months cardiovascular disease
•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 glucocorticoids)
•Untreated or uncontrolled thyroid disease
•Pregnancy or breastfeeding
•Alcohol consumption > 2-drinks per day or other substance abuse.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the effect of metformin on fasting and postprandial GLP-1 and GIP secretion in adults with T1DM.;<br> Secondary Objective: 1. To determine the effect of metformin on glycemic variability in adults with T1DM.<br> 2. To determine the effect of metformin on plasma amino acids and metabolites profile in adults with T1DM.<br> 3. To determine the effect of metformin on inflammation in adults with T1DM.<br> 4. To evaluate the effect of metformin on the microbiome in adults with T1DM.<br> ;Primary end point(s): The primary endpoint will be glucagon like peptide 1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) secretion following a mixed meal.;Timepoint(s) of evaluation of this end point: 36 months

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 36 months;<br> Secondary end point(s): •Change in glycemic variability<br> •Change in plasma amino acids and metabolites profiling<br> •Change in plasma markers of inflammation and adhesion molecules<br> •Change in genes expression related to inflammation and endothelial function<br> •Change in the intestinal microbiome<br>