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van CCT (UK)

van CCT (UK)

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

- candidate number24331
- NTR NumberNTR5853
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-mei-2016
- Secondary IDsNL56309.091.16 
- Public TitleThe influence of metformin and a hypocaloric diet on thyroid radioactive iodide uptake in healthy volunteers: a pilot study
- Scientific TitleThe influence of metformin and a hypocaloric diet on thyroid radioactive iodide uptake in healthy volunteers: a pilot study
- ACRONYMthyroid iodide uptake study 1
- hypothesisuse of metformin and a hypocaloric diet result in reduced thyroid iodide uptake.
- Healt Condition(s) or Problem(s) studiedThyroid disease
- Inclusion criteria. male
. No mental illness
. lnformed consent
. Healthy, specifically no history of thyroid disease or renal insufficiency
. Aged between 18-50 years
. Normal weight (BMl: '18.5-25.0 kg/m2)
. Maintained stable body weight for previous 6 months
- Exclusion criteria. Mentally incompetent
. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 9-mei-2016
- planned closingdate31-mei-2017
- Target number of participants17
- Interventionsgroup1: 2 week course of metformin and iodide restricted diet
Group 2: 2 week course of hypocaloric, iodide restricted diet
Groep 3 (control group): 2 week course of iodide restricted diet
- Primary outcomeThyroid I-123 uptake.
- Secondary outcomethyroid function in terms of TSH, fT4 and T3 measurements.
- Timepoints- 2 week course of iodide restricted diet, followed by baseline measurements of thyroid function and thyroid radioactive iodide uptake
- 2 week intervention period, followed by measurements of thyroid function and thyroid radioactive iodide uptake after intervention
- Trial web site
- statusstopped: trial finished
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryRationale: Treatment with radioactive iodide (RAI) is a widely used and highly efficient treatment for benign and malignant thyroid diseases, such as differentiated thyroid cancer (TC). Specific thyroid iodide uptake is needed to assure effective RAI treatment in TC, which is facilitated by the expression of a sodium-iodide symporter (NIS) on the thyroid cell. Factors that influence either positively or negatively the NIS expression and function could affect the response to RAI treatment. It has been shown that that activation of AMP-activated- protein-kinase (AMPK) leads to decreased NIS expression and iodide uptake in in vitro studies and animal models. For this reason we will focus in this study on modulators of AMPK activity in relation to thyroid iodide uptake in humans. The first important modulator of AMPK is metformin, a well known drug in the treatment of type 2 diabetes mellitus (DM). Because there is evidence that thyroid disease and DM are closely linked and metformin is investigated as important adjunct in the treatment of TC, we estimate that there is a large group of patients that use metformin who undergo RAI treatment, making it interesting to investigate the effects of metfromin on thyroid iodide uptake. Secondly, we want to investigate the effects of a hypocaloric diet, since hypocaloric conditions also induce AMPK activation. During RAI treatment for TC, patients undergo thyroid hormone withdrawal or administration of rhTSH to stimulated thyroid iodide uptake. Thyroid hormone withdrawal results in symptomatic hypothyroidism, leading to complaints such as weight gain and nausea, which could result in reduced food intake and thus hypocaloric conditions. Since this could influence AMPK activation and thus thyroid iodide uptake and RAI efficacy, it is relevant to investigate the effect of altered caloric intake on thyroid iodide uptake.

Objective: To assess the physiological effects of metformin and hypocaloric dieting on thyroid iodide uptake and thyroid function in healthy volunteers.

Study design: This is an investigator initiated interventional pilot study.

Study population: 17 healthy male volunteers, aged 18-50 years.

Intervention: The first group of 7 subjects will follow a two week course of metformin according a specific dosing scheme and follow an iodide restricted diet. Group 2 with 7 subjects will follow a hypocaloric diet (40% caloric restriction, high fat, low carbohydrate content) with an iodide restricted diet for two weeks. There will be a control group of 3 subjects to assess the degree of intra- individual variation in thyroid iodide uptake, who will only follow a iodide restricted diet.

Main study parameters/endpoints: Primary endpoint is the change observed in 123 I thyroid uptake measured by Radioactive iodide uptake testing (RAIU) before and after either metformin or hypocaloric dieting. Secondary endpoints are the changes in serum levels of TSH, fT4 and T3 before and after intervention.
- Main changes (audit trail)16-sept-2016: Participants are no longer required to follow a strict iodide restricted diet. Instead, participants will be instructed to avoid using certain products which contain large amounts of iodide during the study. This setup is more in accordance with clinical practice.
- RECORD10-mei-2016 - 16-feb-2018

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