NCT04879511

Brief Summary

Cardiovascular disease is the leading cause of mortality in type 1 diabetes mellitus (T1DM). Vascular dysfunction is an early and critical event in the development of cardiovascular disease. Children with T1DM have vascular dysfunction therefore early interventions to improve vascular health are essential to reduce cardiovascular mortality in T1DM. Metformin is an insulin sensitising agent which is known to improve vascular health outcomes in type 2 diabetes mellitus (T2DM) and other individuals with insulin resistance. It has been used safely in children and adolescents with T2DM for over 10 years. This study aims to assess the effect of metformin on vascular health in children with T1DM. This is the first study to study effect of metformin on circulating neuregulin-4 levels as a marker for subclinical atherosclerosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2018

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
Last Updated

May 10, 2021

Status Verified

May 1, 2021

Enrollment Period

2.9 years

First QC Date

April 30, 2021

Last Update Submit

May 6, 2021

Conditions

Effect of Change in T1DM Glycemic Control

Keywords

Neuregulin-4metforminType 1 diabetes

Outcome Measures

Primary Outcomes (1)

  • Glycemic control(HbA1c%)

    Effect of metformin supplementation on Glycemic control(HbA1c%)

    up to 24 weeks

Secondary Outcomes (1)

  • circulating neuregulin-4 level

    up to 24 weeks

Study Arms (2)

Receiving metformin

ACTIVE COMPARATOR

Active group receiving metformin with basal /bolus insulin

Drug: metforminDrug: Basal/bolus insulin

Placebo

PLACEBO COMPARATOR

Control group receiving Placebo with basal/bolus insulin

Drug: Basal/bolus insulin

Interventions

metforminDRUG

Oral hypoglycemic drug metformin

Also known as: Glucophage
Receiving metformin
Basal/bolus insulinDRUG

Basal/bolus insulin

PlaceboReceiving metformin

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with type 1 diabetes mellitus (5 years duration at least) and with micro-vascular complications.
  • Patients on regular visits to clinic.
  • Patients on regular insulin therapy.

You may not qualify if:

  • Any clinical evidence of infection, hematological diseases, tumors, liver dysfunction, urinary tract disorders, connective tissue disease, or other autoimmune diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nancy Elbarbary

Cairo, 11361, Egypt

Location

Related Publications (3)

  • Chen Q, Thompson J, Hu Y, Das A, Lesnefsky EJ. Metformin attenuates ER stress-induced mitochondrial dysfunction. Transl Res. 2017 Dec;190:40-50. doi: 10.1016/j.trsl.2017.09.003. Epub 2017 Sep 28.

    PMID: 29040818BACKGROUND

  • Chen LL, Peng MM, Zhang JY, Hu X, Min J, Huang QL, Wan LM. Elevated circulating Neuregulin4 level in patients with diabetes. Diabetes Metab Res Rev. 2017 May;33(4). doi: 10.1002/dmrr.2870. Epub 2016 Dec 27.

    PMID: 27862843BACKGROUND

  • Kocak MZ, Aktas G, Erkus E, Yis OM, Duman TT, Atak BM, Savli H. Neuregulin-4 is associated with plasma glucose and increased risk of type 2 diabetes mellitus. Swiss Med Wkly. 2019 Oct 27;149:w20139. doi: 10.4414/smw.2019.20139. eCollection 2019 Oct 21.

    PMID: 31656034BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Nancy S Elbarbary, MD.PhD

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.of Pediatrics

Study Record Dates

First Submitted

April 30, 2021

First Posted

May 10, 2021

Study Start

February 10, 2018

Primary Completion

January 1, 2021

Study Completion

January 29, 2021

Last Updated

May 10, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)