Effect of Metformin on Gut Microbiota Changes and Glycemic Control of Newly Diagnosed Type 2 Diabetes

NCT04426422 | Completed Phase 4 DMC

• 1 other identifier: GUTT2DM
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This study was aimed to investigate the effect of metformin on the gut microbiota and glycemic control in newly diagnosed type 2 diabetes patients.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• gut micribiota

  the changes of gut micribiota

  3 months

Secondary Outcomes (1)

• glycemic control

  3 months

Study Arms (1)

metformin group

EXPERIMENTAL

all the patients were treated with metformin 1500-2000mg daily for 3 months.

Drug: Metformin Hydrochloride

Interventions

Metformin Hydrochloride DRUG

treated with metformin 1500-2000mg daily

Also known as: intervention group

metformin group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• newly diagnosis type 2 diabetes ,HbA1c \>7 %

You may not qualify if:

• history of cardiovascular disease, hypertension, severe renal dysfunction defined as glomerular filtration rate \< 45 mL/min/1.73 m2; severe illness or diabetic ketoacidosis within 30 days, inability to tolerate ≥500 mg metformin twice per day and pregnancy.

Sponsors & Collaborators

• Shenzhen People's Hospital: lead

Study Sites (1)

Shenzhen People' S Hospital

Shenzhen, Guangdong, 518000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• fengyi Yuan

  Shenzhen People' hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: newly diagnosed type 2 diabetes was treated with metfomin for 3 months.

Study Record Dates

• First Submitted: June 7, 2020
• First Posted: June 11, 2020
• Study Start: March 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: September 30, 2018
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)