Metformin Induces a Dietary Restriction-like State in Human
Chronic Metformin Treatment Induces a Dietary Restriction-like State in Overweight Human
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2016
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedFirst Posted
Study publicly available on registry
April 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedApril 26, 2016
April 1, 2016
8 months
April 1, 2016
April 22, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
The differences of gene expression profile among 3 groups.
The gene expression profile will be checked by microarray, and compared the number differences of pathways among 3 groups.
6 months
Secondary Outcomes (1)
The differences of insulin sensitivity in 3 groups
6 months
Study Arms (3)
Metformin group
EXPERIMENTALMetformin 0.85 twice daily for 6 months
Standard diet group
NO INTERVENTIONCR group
OTHERCalorie restriction diet will be given to this group.
Interventions
Eligibility Criteria
You may qualify if:
- Overweight
- Male
You may not qualify if:
- Female
- Obesity
- Using any other drugs
- \< 18 years old
- \> 60 years old
- Mental disorders
- Surgery history for abdomen
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiang Guang-dalead
Study Sites (1)
Zhang Jiajia
Wuhan, Hubei, 430070, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Guangda Xiang, MD,PhD
Wuhan General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of Endocrinol Dept.
Study Record Dates
First Submitted
April 1, 2016
First Posted
April 20, 2016
Study Start
April 1, 2016
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
April 26, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will share