Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
18 participants
OBSERVATIONAL
2015-08-31
2018-08-30
Brief Summary
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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
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Hypothyroid patients
Hypothyroid patients treated with Levothyroxine as part of normal treatment.
Levothyroxine
Normal treatment with levothyroxine.
Healthy volunteers
Matched on age and BMI. 18 Persons.
No interventions assigned to this group
Interventions
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Levothyroxine
Normal treatment with levothyroxine.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female
Exclusion Criteria
* Male
* Not able to understand written and spoken danish
* Pregnancy
* Thyroidectomized patients
* Amiodarone treatment.
20 Years
75 Years
FEMALE
No
Sponsors
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Center for Diabetes Research, Herlev and Gentofte Hospital.
UNKNOWN
Herlev Hospital
OTHER
Responsible Party
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Bjarke Borregaard Medici
Principial Investigator
Principal Investigators
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Bjarke B Medici, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine, Herlev and Gentofte hospitals.
Locations
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Center for Diabetes Research, Herlev and Gentofte Hospitals
Copenhagen, Capital Region, Denmark
Countries
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Other Identifiers
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Herlev-Gentofte Hypomafia
Identifier Type: -
Identifier Source: org_study_id
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