HypothyroidismHypomafiaNCT02993562
Hypothyroidism, Metabolism and Food Intake
An observational study of Hypothyroidism, run by Herlev Hospital at 1 site in Denmark.
Trial summary
This project has the following primary aims: To measure changes in appetite and food intake in newly diagnosed hypothyroid patients during the first six months after starting levothyroxine (L-T4) substitution therapy Secondary aims are: To delineate the effect of L-T4 substitution therapy on thyroid status, body… Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Hypothyroidism
- What is being tested?
- Levothyroxine
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2015to 30 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 18 Hypothyroid female patients with a TSH > 10 without Levothyroxine treatment.
Who may be able to join
- TSH > 10
- Female
Who cannot join
- Competing serious disease
- Male
- Not able to understand written and spoken danish
- Pregnancy
- Thyroidectomized patients
- Amiodarone treatment.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Diabetes Research, Herlev and Gentofte Hospitals
Copenhagen, Capital Region, 2900
About this study
Official title: Levothyroxine Substitution Therapy in Hypothyroid Patients - Impact on Appetite and Food Intake
This project has the following primary aims:
To measure changes in appetite and food intake in newly diagnosed hypothyroid patients during the first six months after starting levothyroxine (L-T4) substitution therapy
Secondary aims are:
To delineate the effect of L-T4 substitution therapy on thyroid status, body weight, body mass index (BMI), body composition, physical activity, glycaemic control, postprandial gut and pancreatic hormone responses, gastric and gall bladder emptying, resting energy expenditure (REE), quality of life (QOL) and cognitive function
Read the detailed description
18 newly diagnosed hypothyroid female patients and 18 healthy controls age between 20 and 75 years will be recruited from the out-patients clinic in Herlev and Gentofte Hospital and the general practitioners before start of substitution therapy.
The study is devided in to three identical experimental days of approx. 6 hours. First experimental day placed before T4 treatment is initiated. Second day as soon as Thyroid Stimulating Hormone (TSH) is below 4 milli unit pr liter (mU/l). The Third experimental day after 6 months of T4 therapy.
For 5-7 days before each experimental day, the participants' physical activity energy expenditure (PAEE) will be monitored by an Actiheart® pedometer attached to the skin of the chest.
The last two days before each experimental day, the participants will follow a standardised diet following World Health Organization guidelines on energy requirements and nutrient composition according to gender, age and body weight Shortly after diagnosis patients will undergo a test panel at the first experimental day, where patients arrives fasting.
Visual analog score on satiety and thirst will be filled out continuously. REE will be measured by a CCM-express calorimeter,
- Dual Energy X-ray absorptiometry (DEXA)-scan
- Blood samples will be taken continuously during the experimental day. Gall bladder size will be examined at 6 times during the experimental day using ultra sound.
At the end of the day, patients´ satiety will be examined with an ad libitum meal.
Blood will be analysed for Gastric inhibitory polypeptide (GIP), Glucagon-like Peptide 1 (GLP-1), Glucagon-like Peptide 2 (GLP-2), glucagon, peptide tyrosine tyrosine (PYY), Gastrin, Cholesystokinin (CCK), Insulin, C-peptide, Blood sugar, Cholesterol, Free fatty acids and paracetamol.
- Conditions
- Hypothyroidism
- Being tested
- Levothyroxine
- Keywords
- Food intake, Resting Energy Expenditure, Gall Bladder emptying, Insulin response, Body Composition
- Medical subject headings
- Hypothyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevothyroxineDrug
Also called Eltroxin/Euthyrox
Normal treatment with levothyroxine.
| Study group | Role | What they receive |
|---|---|---|
| Hypothyroid patients | Hypothyroid patients treated with Levothyroxine as part of normal treatment. Receives: Drug: Levothyroxine | |
| Healthy volunteers | Matched on age and BMI. 18 Persons. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in food intake at ad libitum meal
Changes in food intake at ad libitum meal measured at each experimental day
Measured: 6 months
Satiety
Satiety measured on a visual analog score 13 times during each experimental day.
Measured: 6 months
Secondary outcomes (16)
Changes in lean mass assessed through lean mass
Changes in lean mass assessed through lean mass with DEXA-scan
Measured: 6 months
Changes in fat mass assessed through lean mass with DEXA-scan
Changes in lean mass assessed through lean mass with DEXA-scan
Measured: 6 months
Changes in gall bladder emptying
Changes in gall bladder emptying evaluated with ultrasound 6 times each experimental day before and after meal.
Measured: 6 months
Changes in resting energy expenditure
Changes in resting energy expenditure measured 3 times each experimental day using Indirect Calorimetry.
Measured: 6 months
Changes in blood sugar response to standardized meal.
changes in blood sugar response to standardized meal measured before and after meal at each experimental day.
Measured: 6 Months
Changes in stomach emptying
Evaluated with continously measuring serum paracetamol after standardized meal containing 1,5 g paracetamol.
Measured: 6 months
Changes in GIP hormones
Continously measuring of a range of hormones during each experimental day: GIP
Measured: 6 months
Changes in GLP-1 hormones
Continously measuring of GLP-1 hormones during each experimental day
Measured: 6 months
Changes in GLP-2 hormones
Continuously measuring of GLP-2 hormones during each experimental day
Measured: 6 Months
Changes in PYY hormones
Continuously measuring of PYY hormones during each experimental day
Measured: 6 Months
Changes in CCK hormones
Continuously measuring of CCK hormones during each experimental day
Measured: 6 Months
Changes in Gastrin hormones
Continuously measuring of Gastrin during each experimental day
Measured: 6 Months
Changes in Insulin hormones
Continuously measuring of Insulin during each experimental day
Measured: 6 Months
Changes in Glucagon
Continuously measuring of Glucagon during each experimental day
Measured: 6 Months
Changes in C-peptide
Continuously measuring of C-peptide during each experimental day
Measured: 6 Months
Changes in Free-Fatty acids
Continuously measuring of Free Fatty acids during each experimental day
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startAug 2015
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Diabetes Research, Herlev and Gentofte Hospital.
- Responsible party
- Principal investigator, Bjarke Borregaard Medici, Herlev Hospital
- Investigators
- Bjarke B Medici, MD, Principal investigator, Department of Internal Medicine, Herlev and Gentofte hospitals.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993562
- Sponsor's protocol ID
- Herlev-Gentofte Hypomafia
- Acronym
- Hypomafia
- Status last verified
- Nov 2018
- First submitted
- 20 Oct 2016
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levothyroxine Substitution Therapy in Hypothyroid Patients - Impact on Appetite and Food Intake
- ClinicalTrials.gov ID
- NCT02993562
- Acronym / sponsor ID
- Hypomafia / Herlev-Gentofte Hypomafia
- Conditions
- Hypothyroidism
- Keywords
- Food intake, Resting Energy Expenditure, Gall Bladder emptying, Insulin response, Body Composition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- Center for Diabetes Research, Herlev and Gentofte Hospital.
- Study start
- Aug 2015
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 15 Dec 2016 (estimated)
- 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.
This project has the following primary aims:
To measure changes in appetite and food intake in newly diagnosed hypothyroid patients during the first six months after starting levothyroxine (L-T4) substitution therapy
Secondary aims are:
To delineate the effect of L-T4 substitution therapy on thyroid status, body weight, body mass index (BMI), body composition, physical activity, glycaemic control, postprandial gut and pancreatic hormone responses, gastric and gall bladder emptying, resting energy expenditure (REE), quality of life (QOL) and cognitive function
Detailed description
18 newly diagnosed hypothyroid female patients and 18 healthy controls age between 20 and 75 years will be recruited from the out-patients clinic in Herlev and Gentofte Hospital and the general practitioners before start of substitution therapy.
The study is devided in to three identical experimental days of approx. 6 hours. First experimental day placed before T4 treatment is initiated. Second day as soon as Thyroid Stimulating Hormone (TSH) is below 4 milli unit pr liter (mU/l). The Third experimental day after 6 months of T4 therapy.
For 5-7 days before each experimental day, the participants' physical activity energy expenditure (PAEE) will be monitored by an Actiheart® pedometer attached to the skin of the chest.
The last two days before each experimental day, the participants will follow a standardised diet following World Health Organization guidelines on energy requirements and nutrient composition according to gender, age and body weight Shortly after diagnosis patients will undergo a test panel at the first experimental day, where patients arrives fasting.
Visual analog score on satiety and thirst will be filled out continuously. REE will be measured by a CCM-express calorimeter,
- Dual Energy X-ray absorptiometry (DEXA)-scan
- Blood samples will be taken continuously during the experimental day. Gall bladder size will be examined at 6 times during the experimental day using ultra sound.
At the end of the day, patients´ satiety will be examined with an ad libitum meal.
Blood will be analysed for Gastric inhibitory polypeptide (GIP), Glucagon-like Peptide 1 (GLP-1), Glucagon-like Peptide 2 (GLP-2), glucagon, peptide tyrosine tyrosine (PYY), Gastrin, Cholesystokinin (CCK), Insulin, C-peptide, Blood sugar, Cholesterol, Free fatty acids and paracetamol.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypothyroid patients | – | Drug: LevothyroxineHypothyroid patients treated with Levothyroxine as part of normal treatment. |
| Healthy volunteers | – | –Matched on age and BMI. 18 Persons. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18 Hypothyroid female patients with a TSH > 10 without Levothyroxine treatment.
Key inclusion criteria (2 listed)
- TSH > 10
- Female
Key exclusion criteria (6 listed)
- Competing serious disease
- Male
- Not able to understand written and spoken danish
- Pregnancy
- Thyroidectomized patients
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 |
|---|---|---|
| LevothyroxineAlso: Eltroxin/EuthyroxNormal treatment with levothyroxine. | Drug | Hypothyroid patients |
Primary outcome
Changes in food intake at ad libitum meal
Time frame: 6 months
Changes in food intake at ad libitum meal measured at each experimental day
Satiety
Time frame: 6 months
Satiety measured on a visual analog score 13 times during each experimental day.
16 secondary outcomes
Changes in lean mass assessed through lean mass
Time frame: 6 months
Changes in fat mass assessed through lean mass with DEXA-scan
Time frame: 6 months
Changes in gall bladder emptying
Time frame: 6 months
Changes in resting energy expenditure
Time frame: 6 months
Changes in blood sugar response to standardized meal.
Time frame: 6 Months
Changes in stomach emptying
Time frame: 6 months
Changes in GIP hormones
Time frame: 6 months
Changes in GLP-1 hormones
Time frame: 6 months
Changes in GLP-2 hormones
Time frame: 6 Months
Changes in PYY hormones
Time frame: 6 Months
Changes in CCK hormones
Time frame: 6 Months
Changes in Gastrin hormones
Time frame: 6 Months
Changes in Insulin hormones
Time frame: 6 Months
Changes in Glucagon
Time frame: 6 Months
Changes in C-peptide
Time frame: 6 Months
Changes in Free-Fatty acids
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- 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. This study is not recruiting at the moment.
Bjarke B Medici, MD principal investigator
Department of Internal Medicine, Herlev and Gentofte hospitals.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothyroidism, run by Herlev Hospital at 1 site in Denmark.
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 6 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: finished, as of the sponsor's last update on 6 Nov 2018. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in food intake at ad libitum meal (time frame: 6 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 6 Nov 2018.