Impact of Thyroid Hormones on Human Glucose and Energy Metabolism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Ulm
About this trial
The goal of this clinical trial to clarify the impact of changes in thyroid hormone levels on glucose and lipid metabolism.
Patients will be included in whom thyroid hormone levels are intentionally changed by treatment. In patients with Graves' disease, thyroid hormone levels will be lowered using medication, while in patients with thyroid cancer, thyroid hormone levels will be raised using medication. Oral glucose tolerance tests will be performed before treatment and at two time points after treatment begins to assess metabolic effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients with initial diagnosis of graves disease OR
patients with initial diagnosis of thyroid carcinoma
Disqualifiers
contraindications for oral glucose tolerance test
Diabetes mellitus
Fasting glucose level ≥ 200 mg/dL
Exogenous insulin administration with action at the time of the test
Trial design
Design model
Single group
Treatments tested in this trial
Oral Glucose Tolerance Test
Other interventionParticipants will receive a 75 g oral glucose tolerance (3h) before the start of treatment, two weeks and three months after start of treatment. Body composition will measured by bioimpedance analysis. Before and during the oral glucose tolerance test, indirect calometry will assess metabolic flexibility.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Phenotyping CohortOther 1 intervention
Trial outcomes
Primary outcomes
1
Insulin sensitivity
Effect of changes in thyroid hormone levels on whole-body insulin sensitivity, assessed from glucose and insulin measurements during the 75 g oral glucose tolerance test.
Time frame
Baseline, 2 weeks, 3 months2
Insulin secretion
Effect of changes in thyroid hormone levels on insulin secretion, assessed from glucose and insulin/c-peptide measurements during the 75 g oral glucose tolerance test.
Time frame
Baseline, 2 weeks, 3 monthsSecondary outcomes
1
Resting energy expenditure.
Effect of changes in thyroid hormone levels on resting energy expenditure assessed by indirect calometry before and during the 75 g oral glucose tolerance test.
Time frame
Baseline, 2 weeks, 3 months2
Respiratory Quotient
Effect of changes in thyroid hormone levels on respiratory quotient assessed by indirect calometry before and during the 75 g oral glucose tolerance test.
Time frame
Baseline, 2 weeks, 3 months3
Lipid metabolism
Effect of changes in thyroid hormone levels on lipid metabolism assessed from lipid measurements during the 75 g oral glucose tolerance test.
Time frame
Baseline, 2 weeks, 3 months4
Hepatic steatosis
Presence of hepatic steatosis assessed by liver ultrasound including elastography.
Time frame
baselineOther outcomes
1
Perceived quality of life
Quality of life assessed by the World Health Organization Quality of Life- Brief (BREF) Questionnaire on a 0-100 scale where higher values indicate better quality of life.
Time frame
either at baseline, two weeks or three months2
Perceived chronic stress
Perceived chronic stress in the last three months assessed through the trier inventory for chronic stress (TICS-9) on a 0-45 scale on which higher values indicate higher chronic stress.
Time frame
cross-sectional either at baseline, two weeks or three months3
Perceived Stress in the last month
Perceived stress in the last months assessed through Perceived Stress Scale (PSS) on a 0-40 scale where higher values indicate higher perceived stress
Time frame
cross-sectional either at baseline, two weeks or three months4
Somatization, anxiety and depression
Somatization, anxiety and depression assessed through the Brief symptom inventory (BSI-18) on a 0-77 scale where higher values indicate higher distress
Time frame
cross-sectional either at baseline, two weeks or three monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov