Metformin and placebo effects on TSH and thyroid volume in patients with pre-diabetes

Phase 2

Conditions: Condition 1: Thyroid gland. Condition 2: Prediabetes.
Disorders of thyroid gland
Impaired glucose tolerance
E00-E07,E0

Registration Number: IRCT2013121215765N1

Lead Sponsor: Isfahan Endocrine and Metabolism Research Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 76

Inclusion Criteria

Inclusion criteria :patients with pre-diabetes [Impaired fasting plasma glucose (100 to 125 mg/dl) or impaired glucose tolerance (IGT) (2-h PG OGTT values of 140–199 mg/dL and having 18 to 65 years old] were initially included.

Exclusion criteria:

Those patients with thyroid malignancy or any other malignancy; previous-thyroxin suppression therapy at any time; obesity due to endocrine disease; Pregnancy and lactation; renal failure or liver failure; neurological or psychological disorders (depression, epilepsy, schizophrenia); heart failure; hypothyroidism or hyperthyroidism; smoking and finally iodinated contrast material exposure in the previous 6 months ago all were excluded from the study.

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Thyroid Stimulating Hormone. Timepoint: Baseline and 3 months later. Method of measurement: TSH : were performed using immunoassay system by an automated analyzer Siemens 2010 (ADVIA Centaur CP Immunoassay System).;Thyroid volume. Timepoint: Before and after 3 months treatment. Method of measurement: Thyroid ultrasonography was performed by single physician, who was unaware of the patients’ any clinical conditions, using a 7 - 9 MHz linear probe ( Logiq 500 Pro, GE Medical Systems, WI, USA).

Secondary Outcome Measures

Name	Time	Method
Thyroid Nodule. Timepoint: Baseline and 3 months later. Method of measurement: Thyroid ultrasound by logic 500 general electric probe 7-9.;IR=Homeostasis Model Assessment Of Insulin Resistance. Timepoint: Baseline and 3 months later. Method of measurement: HOMA-IR ={ Insulin(mU/L) × Fasting Blood glucose(mmol/L)}÷22.5.