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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02745886
Other study ID # Wze2016009
Secondary ID
Status Recruiting
Phase Phase 4
First received April 1, 2016
Last updated April 22, 2016
Start date April 2016
Est. completion date December 2016

Study information

Verified date April 2016
Source Wuhan General Hospital of Guangzhou Military Command
Contact Guangda Xiang, MD
Phone 13517275283
Email Guangda64@hotmail.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

The fact that metformin treatment has been associated with reduced risk of cancer and cardiovascular disease raises the possibility of a beneficial role of metformin for other age-related diseases. The actions of metformin resemble the effects of calorie restriction (CR) to some extent, and microarray analyses have shown that metformin induces a gene expression profile that aligns with that of CR in animal. The aim of the study is to investigate whether metformin treatment can induce dietary restriction-like state in human.

Sixty overweight subjects will be included in this study, and participants will be divided 3 groups (20 cases in each group)including metformin group (0.85, twice daily), standard diet group, and CR group. All subjects will be treated 6 months. At the end of this study, blood samples and muscle samples will be obtained.


Description:

Blood samples will be obtained from all individuals. blood lipids, inflammation markers, insulin, glucose, leptin,adiponectin, ala aminotransferase, asp aminotransferase, creatine phosphokinase,lactate dehydrogenase, alkaline phosphatase,bilirubin, cyclo-oxygenase, citrate synthase, renal function, leukocyte telomere length ratio, and telomerase activity will be measured before and after the treatments.Also, hyperinsulinemic-euglycemic clamp will be performed before and after the treatments. Muscle samples will be obtained by biopsy for 9 individuals (3 cases from each group) at the end of the study. Microarray analysis will be performed for the gene expression profile from the muscle samples. Other protein expressions such asadenosine monophosphate-activated protein kinase (AMPK), peroxisome proliferator-activated receptor coactivator 1a (PGC-1a) activity,will be checked by Western blot.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Overweight

- Male

Exclusion Criteria:

- Female

- Obesity

- Using any other drugs

- < 18 years old

- > 60 years old

- Mental disorders

- Surgery history for abdomen

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
metformin 0.85 twice daily for 6 months

Behavioral:
Calorie restriction


Locations

Country Name City State
China Zhang Jiajia Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Xiang Guang-da

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The differences of gene expression profile among 3 groups. The gene expression profile will be checked by microarray, and compared the number differences of pathways among 3 groups. 6 months Yes
Secondary The differences of insulin sensitivity in 3 groups The insulin sensitivity will be measured by insulin clamp assays, and be compared before and after 6 months as well as among 3 group at the end of this study. 6 months Yes
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