NCT03590262

Brief Summary

Aim Evidence of a possible connection between gut microbiota and several physiological processes linked to type 1 diabetes is increasing. However, the effect of multistrain probiotics in people with type 1 diabetes remains unclear. This study investigated the effect of metformin as add-on therapy on glycemic control and other diabetes-related outcomes in people with type 1 diabetes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

July 20, 2018

Status Verified

May 1, 2018

Enrollment Period

1.2 years

First QC Date

July 6, 2018

Last Update Submit

July 18, 2018

Conditions

Type 1 Diabetes MellitusMetformin

Outcome Measures

Primary Outcomes (1)

  • Change of hemoglobin A1c in percentage

    analyze the change of hemoglobin A1c before and after the treatment

    3 months

Secondary Outcomes (1)

  • Change of weight in kilograms

    3 months

Study Arms (1)

metformin

EXPERIMENTAL

patients take metformin 500mg twice or three times a day as add-on therapy to insulin for 3 months ,using self-control method.

Drug: Metformin

Interventions

MetforminDRUG

take the metformin 500mg twice or three times a day

Also known as: metformin hydrochloride tablets
metformin

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • type 1 diabetes patients age 18-60years old 18 Kg/m2≤BMI≤30Kg/m2 ketonuria (-)；

You may not qualify if:

  • pregnancy lactation having other severe chronic illnesses taking other anti-diabetic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

RECRUITING

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

  • Fengyi Yuan

    associate chief physician

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuzhen Zhang

CONTACT

86-13714902238876538754@qq.com

Ping Xu

CONTACT

86-13692156916

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2018

First Posted

July 18, 2018

Study Start

January 1, 2018

Primary Completion

March 31, 2019

Study Completion

September 30, 2019

Last Updated

July 20, 2018

Record last verified: 2018-05

Locations

CN(1)