Effect of Metformin as add-on Therapy on Glycemic Control and Other Outcomes in Type 1 Diabetes

NCT ID: NCT03590262

Last Updated: 2018-07-20

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-09-30

Brief Summary

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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.

Detailed Description

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Design An open-label, add-on, self-control clinical trial. Setting Diabetes clinic of a teaching hospital in Shenzhen China Participants A total of 20 participants with type 1 diabetes, aged 18-60 years, will be recruited and treated with metformin as add-on therapy with insulin for 12 weeks.

Outcomes Primary outcomes were glycemic control related parameters, and secondary outcomes were anthropomorphic variables, lipid profile, blood pressure and high-sensitivity C-reactive protein. The gut microbiota profile will be analyzed before and after intervention .

Conditions

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Type 1 Diabetes Mellitus Metformin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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metformin

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

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

take the metformin 500mg twice or three times a day

Interventions

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Metformin

take the metformin 500mg twice or three times a day

Intervention Type DRUG

Other Intervention Names

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metformin hydrochloride tablets

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

pregnancy lactation having other severe chronic illnesses taking other anti-diabetic drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenzhen People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fengyi Yuan

Role: PRINCIPAL_INVESTIGATOR

associate chief physician

Locations

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Shenzhen People's Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiuzhen Zhang

Role: CONTACT

86-13714902238

Ping Xu

Role: CONTACT

86-13692156916

Facility Contacts

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Xiuzhen Zhang, MD

Role: primary

0086-755-22943422

Other Identifiers

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723

Identifier Type: -

Identifier Source: org_study_id

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