Type 1 Diabetes Mellitus Clinical Trial
Official title:
Gut-derived Incretin Hormones in the Pathophysiology of Type 1 Diabetes Mellitus; Effect of Metformin Treatment
Investigators aim is to conduct an RCT to study the effect of adjunct metformin treatment to insulin monotherapy in patients with type 1 diabetes, targeting the intestinal incretin secretion. The patients will be randomly allocated to metformin or placebo treatment for 4 months
Compared to the large armamentarium of antidiabetic agents for Type 2 Diabetes Mellitus
(T2DM), the insulinocentric therapeutic approach in Type 1 Diabetes Mellitus (T1DM) has
distracted the scientific perspective from the rise of novel therapies. Insulin monotherapy
has long overshadowed the overall hormonal dysregulation that demarcates T1DM . In specific,
the significance of the gut-derived incretin hormones GLP-1 (glucagon-like peptide 1) and GIP
(glucose-dependent insulinotropic peptide), which are implicated with glucose metabolism via
the gut-pancreatic axis, has been merely addressed.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04476472 -
Omnipod Horizon™ Automated Glucose Control System Preschool Cohort
|
N/A | |
| Completed |
NCT03635437 -
Evaluation of Safety and Diabetes Status Upon Oral Treatment With GABA in Patients With Longstanding Type-1 Diabetes
|
Phase 1/Phase 2 | |
| Completed |
NCT04909580 -
Decision Coaching for Youth and Parents Considering Insulin Delivery Methods for Type 1 Diabetes
|
N/A | |
| Active, not recruiting |
NCT00679042 -
Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol
|
Phase 3 | |
| Completed |
NCT03293082 -
Preschool CGM Use and Glucose Variability in Type 1 Diabetes
|
N/A | |
| Completed |
NCT04016662 -
Automated Insulin Delivery in Elderly With Type 1 Diabetes (AIDE T1D)
|
Phase 4 | |
| Completed |
NCT02527265 -
Afrezza Safety and Pharmacokinetics Study in Pediatric Patients
|
Phase 2 | |
| Completed |
NCT03738865 -
G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes
|
Phase 3 | |
| Completed |
NCT03240432 -
Wireless Innovation for Seniors With Diabetes Mellitus
|
N/A | |
| Completed |
NCT03168867 -
Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)
|
N/A | |
| Completed |
NCT03674281 -
The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System
|
N/A | |
| Completed |
NCT03669770 -
Ultrasound Classification and Grading of Lipohypertrophy and Its Impact on Glucose Variability in Type 1 Diabetes
|
||
| Recruiting |
NCT03682640 -
Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes
|
Phase 2 | |
| Recruiting |
NCT04096794 -
Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research
|
||
| Completed |
NCT02882737 -
The Impact of Subcutaneous Glucagon Before, During and After Exercise a Study in Patients With Type 1 Diabetes Mellitus
|
N/A | |
| Recruiting |
NCT02745808 -
Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes
|
Phase 1 | |
| Completed |
NCT02558491 -
Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM
|
N/A | |
| Completed |
NCT02562313 -
A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®
|
Phase 1 | |
| Withdrawn |
NCT02579148 -
Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes
|
Phase 1 | |
| Completed |
NCT02596204 -
Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring
|
N/A |