the influence of metformin and a low caloric diet on thyroid iodide uptake.

The influence of metformin and a hypocaloric diet on thyroid radioactive iodide uptake in healthy volunteers: a pilot study - the influence of metformin and hypocaloric dieting on thyroid iodide uptake.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001455-42-NL

Enrollment

Registered

2016-04-18

Start date

2016-04-20

Completion date

Unknown

Last updated

2018-10-15

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

Conditions

physiological thyroid function in terms of thyroid iodide uptake and thyroid hormone production knowledge can be extrapolated for treatment of thyroid diseases such as hyperthyroidism and thyroid carcinoma

Interventions

Trade Name: Metformin Product Name: Metformin Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: . male . No mental illness . lnformed consent . Healthy, specifically no history of thyroid disease or renal insufficiency . Aged between 18-50 years . Normalweight (BMl: 18.5-25.0 kg/m2) . Maintained stable body weight for previous 6 months Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 17 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: . Any thyroid condition: hypo- or hyperthyroidism, thyroid cancer, other thyroid conditions. . Any chronic illness, including diabetes mellitus, acute or chronic infections, other disease requiring treatment. . Use of any medication or homeopathic medications. Use of paracetamol is allowed. . Smoking . Previous radioactive iodide scanning or other imaging techniques with administration of iodide containing contrast fluids within 6 months. . Use of supplements that contain large quantities of iodide . Structural alcohol intake > 3 glasses/day . Subjects who have taken part in any drug trial within 3 months prior start of this study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the physiological effects of metformin and hypocaloric dieting on thyroid iodide uptake and thyroid function in healthy volunteers. ;Secondary Objective: not applicable;Primary end point(s): change in thyroid I-123 uptake before and after intervention;Timepoint(s) of evaluation of this end point: Participants will be advised to avoid certain products with high iodide content (mainlyseafood). Baseline measurements will be performed: thyroid I-123 uptake scanning and serum TSH, fT4 and T3. then participants will be devided in 3 intervention groups for a twee week intervention: - group 1 (7 participants): 2 week cours of metformin. - group 2 (7 participants): 2 week course ofahypocaloric diet (40% caloric restriction) - group 3 (3 participants): control group. After intervention, again thyroid I-123 uptake measurements and serum TSH, fT4 and T3 will be performed.	—

Measure

Time frame

Main Objective: To assess the physiological effects of metformin and hypocaloric dieting on thyroid iodide uptake and thyroid function in healthy volunteers. ;Secondary Objective: not applicable;Primary end point(s): change in thyroid I-123 uptake before and after intervention;Timepoint(s) of evaluation of this end point: Participants will be advised to avoid certain products with high iodide content (mainlyseafood). Baseline measurements will be performed: thyroid I-123 uptake scanning and serum TSH, fT4 and T3. then participants will be devided in 3 intervention groups for a twee week intervention: - group 1 (7 participants): 2 week cours of metformin. - group 2 (7 participants): 2 week course ofahypocaloric diet (40% caloric restriction) - group 3 (3 participants): control group. After intervention, again thyroid I-123 uptake measurements and serum TSH, fT4 and T3 will be performed.

—

Secondary

Measure	Time frame
Secondary end point(s): change in serum TSH, fT4 and T3 before and after intervention;Timepoint(s) of evaluation of this end point: Baseline measurements will be performed: thyroid I-123 uptake scanning and serum TSH, fT4 and T3. then participants will be devided in 3 intervention groups for a twee week intervention: - group 1 (7 participants): 2 week cours of metformin. - group 2 (7 participants): 2 week course of a hypocaloric diet (40% caloric restriction) - group 3 (3 participants): 2 week ccontrol group. After intervention, again thyroid I-123 uptake measurements and serum TSH, fT4 and T3 will be performed.	—

Measure

Time frame

Secondary end point(s): change in serum TSH, fT4 and T3 before and after intervention;Timepoint(s) of evaluation of this end point: Baseline measurements will be performed: thyroid I-123 uptake scanning and serum TSH, fT4 and T3. then participants will be devided in 3 intervention groups for a twee week intervention: - group 1 (7 participants): 2 week cours of metformin. - group 2 (7 participants): 2 week course of a hypocaloric diet (40% caloric restriction) - group 3 (3 participants): 2 week ccontrol group. After intervention, again thyroid I-123 uptake measurements and serum TSH, fT4 and T3 will be performed.

—

Countries

Netherlands

Contacts

Public ContactInternal Medicine-Endocrine Disease

Radboud Universitair Medisch Centrum

00310243614599

Outcome results

None listed

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