Metformin and Pioglitazone Effects on YKL-40 Concentrations in Type 2 Diabetes Patients

NCT01963663 | Completed

• 1 other identifier: 92/d/130/499
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with type 2 diabetes are at an increased risk for developing atherosclerosis, largely due to the underlying insulin resistance and chronic low grade inflammation. Cardiovascular events could be prevented with proper interventions targeted at ameliorating the aforementioned detrimental processes. YKL-40, a novel surrogate marker of acute and chronic inflammatory states has been implicated to have a putative role in both pathways. Given the shared pathway of insulin resistance and atherosclerosis, it is conceivable that anti-diabetes medications are able to modify coronary artery disease risk via direct and indirect amelioration of YKL-40 concentrations. The present clinical trial was therefore launched to examine the comparative effects of metformin and pioglitazone, two commonly prescribed anti-diabetes medications on YKL-40 concentrations in medication-naïve, newly-diagnosed type 2 diabetes patients.

Conditions

Type 2 Diabetes Mellitus

Keywords

YKL-40; Chronic low grade inflammation; type 2 diabetes mellitus; metformin; pioglitazone

Outcome Measures

Primary Outcomes (1)

• Serum concentration of YKL-40

  12 weeks

Study Arms (2)

Metformin

ACTIVE COMPARATOR

patients receiving fixed dose metformin 1000 mg daily

Drug: Metformin

Pioglitazone

ACTIVE COMPARATOR

patients receiving fixed dose pioglitazone 30 mg daily

Drug: Pioglitazone

Interventions

Metformin DRUG

metformin 1000 mg daily in two divided doses of 500 mg tablets

Metformin

Pioglitazone DRUG

pioglitazone 30 mg daily in two divided doses of 15 mg tablets

Pioglitazone

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed type 2 diabetes patients based on American Diabetes Association criteria for diagnosis of diabetes

You may not qualify if:

• positive history for taking anti-diabetes medications of any class in the past
• positive current history for taking over-the-counter vitamin or anti-oxidant supplements
• presence of clinically significant chronic illnesses of the heart, lungs, or kidneys.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Diabetes Clinic, Vali-Asr Hospital, Tehran University of Medical Sciences

Tehran, Tehran Province, 13145-784, Iran

Location

Related Publications (1)

• Esteghamati A, Azizi R, Ebadi M, Noshad S, Mousavizadeh M, Afarideh M, Nakhjavani M. The comparative effect of pioglitazone and metformin on serum osteoprotegerin, adiponectin and intercellular adhesion molecule concentrations in patients with newly diagnosed type 2 diabetes: a randomized clinical trial. Exp Clin Endocrinol Diabetes. 2015 May;123(5):289-95. doi: 10.1055/s-0034-1396864. Epub 2015 Jan 21.

  PMID: 25607338 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Alireza Esteghamati, M.D.

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Alireza Esteghamati

Study Record Dates

• First Submitted: October 13, 2013
• First Posted: October 16, 2013
• Study Start: November 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

IR (1)