Metformin Induces a Dietary Restriction-like State in Human

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Abstract

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.

Dates

Last Verified:	03/31/2016
First Submitted:	03/31/2016
Estimated Enrollment Submitted:	04/16/2016
First Posted:	04/19/2016
Last Update Submitted:	04/21/2016
Last Update Posted:	04/25/2016
Actual Study Start Date:	03/31/2016
Estimated Primary Completion Date:	11/30/2016
Estimated Study Completion Date:	11/30/2016

Condition or disease

Overweight Subjects

Metformin

Aging

Intervention/treatment

Drug: Metformin group

Behavioral: CR group

Phase

Phase 4

Arm Groups

Arm	Intervention/treatment
Experimental: Metformin group Metformin 0.85 twice daily for 6 months	Drug: Metformin group
No Intervention: Standard diet group
Other: CR group Calorie restriction diet will be given to this group.	Behavioral: CR group

Eligibility Criteria

Ages Eligible for Study	18 Years To 18 Years
Sexes Eligible for Study	Male
Accepts Healthy Volunteers	Yes
Criteria	Inclusion Criteria: - Overweight - Male Exclusion Criteria: - Female - Obesity - Using any other drugs - < 18 years old - > 60 years old - Mental disorders - Surgery history for abdomen

Outcome

Primary Outcome Measures

1. 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

1. 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.

Metformin Induces a Dietary Restriction-like State in Human

Keywords

lactate dehydrogenase

phosphatase

oxygenase

neoplasms

inflammation

obesity

citrate

alkaline phosphatase

creatine