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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Effect of Metformin as add-on Therapy on Glycemic Control and Other Diabetes‑Related Outcomes in Type 1 Diabetic Patients:a Open-label,Self-control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03590262
• Other study ID #: 723
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: May 2018
• Source: Shenzhen People's Hospital
• Contact: Xiuzhen Zhang
• Phone: 86-13714902238
• Email: 876538754[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 30, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Metformin
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Metformin
take the metformin 500mg twice or three times a day

Locations

Country	Name	City	State
China	Shenzhen People's Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of hemoglobin A1c in percentage	analyze the change of hemoglobin A1c before and after the treatment	3 months
Secondary	Change of weight in kilograms	analyze the change of weight in kilograms before and after the treatment	3 months