Metformin Induces a Dietary Restriction-like State in Human

Phase 4

• Conditions: Overweight Subjects; Aging; Metformin
• Interventions: Drug: metformin 0.85 twice daily for 6 months; Behavioral: Calorie restriction

• Registration Number: NCT02745886
• Lead Sponsor: Xiang Guang-da

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2016-04
• Study Start: 2016-04
• Study First Submitted: 2016-04-01
• Study First Submitted QC: 2016-04-17
• Study First Posted: 2016-04-20
• Last Update Submitted: 2016-04-22
• Last Update Posted: 2016-04-26
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin group	metformin 0.85 twice daily for 6 months	Metformin 0.85 twice daily for 6 months
CR group	Calorie restriction	Calorie restriction diet will be given to this group.

Primary Outcome Measures

Name	Time	Method
The differences of gene expression profile among 3 groups.	6 months	The gene expression profile will be checked by microarray, and compared the number differences of pathways among 3 groups.

Secondary Outcome Measures

Name	Time	Method
The differences of insulin sensitivity in 3 groups	6 months	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.

Trial Locations

Locations (1)

Zhang Jiajia; 🇨🇳 Wuhan, Hubei, China