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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013121215765N1
Enrollment
76
Registered
2014-05-29
Start date
2013-04-01
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Thyroid gland. Condition 2: Prediabetes. Disorders of thyroid gland Impaired glucose tolerance

Interventions

Intervention 1: One group will receive placebo with a sercret code. (Subjects were instructed to take 1 tablet 500 mg placebo daily. But in the 1st week, subjects were instructed to take 2 tablet
Placebo
Treatment - Drugs
One group will receive placebo with a sercret code. (Subjects were instructed to take 1 tablet 500 mg placebo daily. But in the 1st week, subjects were instructed to take 2 tablet 500 mg daily,
The other group will receive metformin with a secret code. (Subjects were instructed to take 1 tablet 500 mg Metformin daily. But in the 1st week, subjects were instructed to take 2 tablet 500 mg dail

Sponsors

Isfahan Endocrine and Metabolism Research Center
Lead Sponsor
Raha Pharmaceutical Company
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMozhgan karimifar

Isfahan Endocrine and Metabolism Research Center

mozh.karimifar@med.mui.ac.ir+98 31 1335 9933

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026