Graves DiseaseNCT07410637
Impact of Thyroid Hormones on Human Glucose and Energy Metabolism
A study testing Oral Glucose Tolerance Test in people with Graves Disease and Thyroid Cancer, run by University of Ulm at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Graves Disease, Thyroid Cancer
- What is being tested?
- Oral Glucose Tolerance Test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 4 Feb 2026to Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with initial diagnosis of graves disease OR
- patients with initial diagnosis of thyroid carcinoma
Who cannot join
- 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
- Current disease with activation of stress hormones
- Post-aggressive metabolism
- Acute infectious disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Ulm University Hospital
Ulm, Baden-Wurttemberg, 89081
Roza Sabia, MD, +4973150044719, roza.sabia@uniklinik-ulm.de
Sabrina Wangler, +4973150044782, sabrina.wangler@uniklinik-ulm.de
About this study
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.
Read the detailed description
This research project aims to clarify the role of changes in thyroid hormone levels in glucose and liver metabolism.
Thyroid hormones regulate endogenous glucose production, insulin sensitivity, lipid metabolism, and lipid storage in the liver. They also appear to enhance insulin sensitivity in other tissues. Furthermore, thyroid hormones stimulate lipolysis and reduce total and LDL-cholesterol levels. The impact of thyroid hormones on insulin secretion is controversial, with some trials demonstrating increased secretion and others showing decreased secretion. Most of this evidence is derived from animal trials, and prospective human trials are lacking.
Clinical scenarios where thyroid hormone levels are altered through therapeutic interventions will be used. In patients with Graves' disease, hyperthyroidism is pharmacologically reduced, whereas in patients with thyroid carcinoma, hyperthyroidism is pharmacologically induced. Before the start of treatment, two weeks and three months after start of treatment oral glucose tolerance tests will be performed for metabolic characterization. Using this approach, differences in glycemic, insulin sensitivity, insulin secretion, lipids, resting energy expenditure, respiratory quotient, hepatic steatosis, eating and exercise behavior will be assessed.
- Conditions
- Graves Disease, Thyroid Cancer
- Being tested
- Oral Glucose Tolerance Test
- Keywords
- thyroid hormones, glucose metabolism, lipid metabolism, graves disease, thyroid cancer, hyperthyroidism
- Medical subject headings
- Graves Disease, Thyroid Neoplasms, Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Glucose Tolerance TestOther
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| Phenotyping Cohort | Other | Patients with Graves' disease and patients with thyroid carcinoma undergoing standard-of-care thyroid treatment. Receives: Other: Oral Glucose Tolerance Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 weeks, 3 months
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.
Measured: Baseline, 2 weeks, 3 months
Secondary outcomes (6)
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.
Measured: Baseline, 2 weeks, 3 months
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.
Measured: Baseline, 2 weeks, 3 months
Lipid metabolism
Effect of changes in thyroid hormone levels on lipid metabolism assessed from lipid measurements during the 75 g oral glucose tolerance test.
Measured: Baseline, 2 weeks, 3 months
Hepatic steatosis
Presence of hepatic steatosis assessed by liver ultrasound including elastography.
Measured: baseline
Heart rate variability
Effect of changes in thyroid hormone levels on heart rate variability assessed by electrocardiography during the 75 g oral glucose tolerance test.
Measured: Baseline, 2 weeks, 3 months
Eating behavior
Effect of changes in thyroid hormone levels on eating behavior assessed by dietary protocols before the start of treatment and 3 months later.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start4 Feb 2026
- Primary completionFeb 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a longitudinal mechanistic study evaluating the metabolic effects of changes in thyroid hormone levels on glucose and liver metabolism. Participants include patients with Graves' disease and patients with thyroid carcinoma undergoing standard-of-care thyroid treatment. The only study-specific intervention is repeated metabolic phenotyping using oral glucose tolerance tests (OGTTs) performed at baseline, two weeks, and three months after initiation of therapy. Thyroid hormone modulation occurs as part of routine clinical care and is not assigned by the study protocol.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Heni, University of Ulm
- Investigators
- Martin Heni, Principal investigator, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410637
- Sponsor's protocol ID
- 173/23
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Thyroid Hormones on Human Glucose and Energy Metabolism
- ClinicalTrials.gov ID
- NCT07410637
- Acronym / sponsor ID
- 173/23
- Conditions
- Graves Disease, Thyroid Cancer
- Keywords
- thyroid hormones, glucose metabolism, lipid metabolism, graves disease, thyroid cancer, hyperthyroidism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- Feb 2031 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This research project aims to clarify the role of changes in thyroid hormone levels in glucose and liver metabolism.
Thyroid hormones regulate endogenous glucose production, insulin sensitivity, lipid metabolism, and lipid storage in the liver. They also appear to enhance insulin sensitivity in other tissues. Furthermore, thyroid hormones stimulate lipolysis and reduce total and LDL-cholesterol levels. The impact of thyroid hormones on insulin secretion is controversial, with some trials demonstrating increased secretion and others showing decreased secretion. Most of this evidence is derived from animal trials, and prospective human trials are lacking.
Clinical scenarios where thyroid hormone levels are altered through therapeutic interventions will be used. In patients with Graves' disease, hyperthyroidism is pharmacologically reduced, whereas in patients with thyroid carcinoma, hyperthyroidism is pharmacologically induced. Before the start of treatment, two weeks and three months after start of treatment oral glucose tolerance tests will be performed for metabolic characterization. Using this approach, differences in glycemic, insulin sensitivity, insulin secretion, lipids, resting energy expenditure, respiratory quotient, hepatic steatosis, eating and exercise behavior will be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a longitudinal mechanistic study evaluating the metabolic effects of changes in thyroid hormone levels on glucose and liver metabolism. Participants include patients with Graves' disease and patients with thyroid carcinoma undergoing standard-of-care thyroid treatment. The only study-specific intervention is repeated metabolic phenotyping using oral glucose tolerance tests (OGTTs) performed at baseline, two weeks, and three months after initiation of therapy. Thyroid hormone modulation occurs as part of routine clinical care and is not assigned by the study protocol.
| Arm | Type | Receives |
|---|---|---|
| Phenotyping Cohort | Other | Other: Oral Glucose Tolerance TestPatients with Graves' disease and patients with thyroid carcinoma undergoing standard-of-care thyroid treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients with initial diagnosis of graves disease OR
- patients with initial diagnosis of thyroid carcinoma
Key exclusion criteria (7 listed)
- 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
- Current disease with activation of stress hormones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Glucose Tolerance TestParticipants 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. | Other | Phenotyping Cohort |
Primary outcome
Insulin sensitivity
Time frame: Baseline, 2 weeks, 3 months
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.
Insulin secretion
Time frame: Baseline, 2 weeks, 3 months
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.
6 secondary outcomes
Resting energy expenditure.
Time frame: Baseline, 2 weeks, 3 months
Respiratory Quotient
Time frame: Baseline, 2 weeks, 3 months
Lipid metabolism
Time frame: Baseline, 2 weeks, 3 months
Hepatic steatosis
Time frame: baseline
Heart rate variability
Time frame: Baseline, 2 weeks, 3 months
Eating behavior
Time frame: Baseline, 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Heni principal investigator
University of Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Glucose Tolerance Test in people with Graves Disease and Thyroid Cancer, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Heni, Prof (+4973150044505, martin.heni@uniklinik-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: Baseline, 2 weeks, 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.