Ignite Creation Date:
2024-05-06 @ 1:16 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01765946
Status:
COMPLETED
Last Update Posted:
2013-03-13
First Post:
2013-01-08
Brief Title:
Metformin and Longevity Genes in Prediabetes
Sponsor:
University of Padova
Organization:
University of Padova
Study Overview
Official Title:
Effects of Metformin on Longevity Gene Expression and Inflammation and Prediabetic Individuals A Placebo-controlled Trial
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pre-diabetes a condition characterized by hyperglycaemia is associated with increased cardiovascular risk and reduced life expectancy as compared to the general population AMP-activated protein kinase AMPK is an enzyme that plays a key role in cellular energy homeostasis and metabolism and recently it has been demonstrated that AMPK regulates aging pathways as well AMPK is susceptible to modulation through pharmacologic eg metformin and non-pharmacologic eg physical exercise interventions This clinical trial aims to describe the effects of the AMPK pathway on longevity genes and inflammation in the setting of pre-diabetes in vivo and in vitro To this end the investigators will compare treatment with metformin 500 mg tid for 2 months versus placebo in pre-diabetic subjects The investigators will assess expression of longevity genes SIRT1 p66Shc p53 and mTOR in peripheral blood mononuclear cells PBMCs ex vivo The investigators will evaluate monocyte polarization by flow cytometry according to the expression of surface antigens CD68 CCR2 CD163 CD206 CX3CR1 to determine the prevalence of pro- or anti-inflammatory cells Inflammatory cytokines TNF-alpha MCP-1 IL-1 IL-6 IL-10 CCL12 will also be determined In the in vitro study the investigators will evaluate the effects of AMPK activation or inhibition on longevity gene and protein expression
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None