Metformin Induces a Dietary Restriction-like State in Human

Aging Clinical Trial

Official title:

Chronic Metformin Treatment Induces a Dietary Restriction-like State in Overweight Human

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02745886
• Other study ID #: Wze2016009
• 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

• Aging
• Metformin
• Overweight
• Overweight Subjects

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