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OpenTrials
Completed

NCT Number: NCT01593371

Comparison of Metformin and Pioglitazone Effects on Adipokines Concentrations in Newly Diagnosed Type 2 Diabetes Patients

Oral hypoglycemic agents encompass the mainstay of treatment in the majority of patients with type 2 diabetes. Thiazolidinediones (such a pioglitazone) and Biguanides (such as metformin), are two major groups of hypoglycemic medications that while function via different pathways, are both effective in short- and long-term glycemic control . These medications diminish or at least delay long term micro- and macrovascular complications associated with prolonged insulin resistance although at different rates. The mechanisms by which this aim is achieved, nevertheless, remains largely unclear. With adipokines playing a key role in development of both insulin resistance and atherosclerosis, oral hypoglycemic agents might regulate these substances by direct and indirect routes.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tehran University of Medical Sciences

Tehran, Tehran Province, 13145-784, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newly diagnosed type 2 diabetes patients based on American Diabetes Association criteria (2011) for diagnosis of diabetes

Exclusion criteria

  • previous intake of oral hypoglycemic agents for treatment of diabetes or other hyperglycemia associated conditions
  • intake of glucocorticoids in the past one year
  • major illnesses of heart, lung, kidney, and liver.

Treatment and study plan

metformin

Drug

Metformin 1000 mg fixed dose, twice daily (500 mg tablets x 2)

pioglitazone

Drug

Pioglitazone 30 mg fixed dose, twice daily (15 mg tablets x 2)

Primary outcomes

  1. Serum concentrations of omentin

    Time frame: 12 weeks

    Serum concentrations of adipose tissue derived cytokine omentin

  2. Serum concentrations of leptin

    Time frame: 12 weeks

    Serum concentrations of adipose tissue derived cytokine leptin

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

Comparing Effects of Metformin and Pioglitazone on Regulation of Serum Adipokines in Newly Diagnosed Type 2 Diabetes Patients

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
May 8, 2012
Registry last updated
May 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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