Metformin Induces a Dietary Restriction-like State in Human

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02745886

Enrollment

Registered

2016-04-20

Start date

2016-04-30

Completion date

2016-12-31

Last updated

2016-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Metformin, Overweight Subjects

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.

Interventions

DRUGmetformin 0.85 twice daily for 6 months

BEHAVIORALCalorie restriction

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Overweight * Male

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactGuangda Xiang, MD

Guangda64@hotmail.com13517275283

Backup ContactGuangda Xiang, MD,PhD

Guangda64@hotmail.com02750772198

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026