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Metformin Induces a Dietary Restriction-like State in Human

Sponsor
Xiang Guang-da (Other)
Overall Status
Unknown status
CT.gov ID
NCT02745886
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
8
Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: metformin 0.85 twice daily for 6 months
  • Behavioral: Calorie restriction
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Chronic Metformin Treatment Induces a Dietary Restriction-like State in Overweight Human
Study Start Date :
Apr 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Metformin group

Metformin 0.85 twice daily for 6 months

Drug: metformin 0.85 twice daily for 6 months
No Intervention: Standard diet group
Other: CR group

Calorie restriction diet will be given to this group.

Behavioral: Calorie restriction

Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
Male
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhang Jiajia Wuhan Hubei China 430070

Sponsors and Collaborators

  • Xiang Guang-da

Investigators

  • Study Chair: Guangda Xiang, MD,PhD, Wuhan General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiang Guang-da, Director of Endocrinol Dept., Wuhan General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier:
NCT02745886
Other Study ID Numbers:
  • Wze2016009
First Posted:
Apr 20, 2016
Last Update Posted:
Apr 26, 2016
Last Verified:
Apr 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:
Overweight
Metformin

Study Results

No Results Posted as of Apr 26, 2016