Metformin Induces a Dietary Restriction-like State in Human

NCT ID: NCT02745886

Last Updated: 2016-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Overweight Subjects Metformin Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin group

Metformin 0.85 twice daily for 6 months

Group Type EXPERIMENTAL

metformin 0.85 twice daily for 6 months

Intervention Type DRUG

Standard diet group

Group Type NO_INTERVENTION

No interventions assigned to this group

CR group

Calorie restriction diet will be given to this group.

Group Type OTHER

Calorie restriction

Intervention Type BEHAVIORAL

Interventions

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metformin 0.85 twice daily for 6 months

Intervention Type DRUG

Calorie restriction

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Overweight
* Male

Exclusion Criteria

* Female
* Obesity
* Using any other drugs
* \< 18 years old
* \> 60 years old
* Mental disorders
* Surgery history for abdomen
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Xiang Guang-da

OTHER

Sponsor Role lead

Responsible Party

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Xiang Guang-da

Director of Endocrinol Dept.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Guangda Xiang, MD,PhD

Role: STUDY_CHAIR

Wuhan General Hospital

Locations

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Zhang Jiajia

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guangda Xiang, MD

Role: CONTACT

13517275283

Guangda Xiang, MD,PhD

Role: CONTACT

02750772198

Facility Contacts

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Guangda Xiang, MD, PhD

Role: primary

02750772981

Other Identifiers

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Wze2016009

Identifier Type: -

Identifier Source: org_study_id

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