- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02993562
Hypothyroidism, Metabolism and Food Intake (Hypomafia)
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
Przegląd badań
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Region Hovedstaden
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Copenhagen, Region Hovedstaden, Dania, 2900
- Center for Diabetes Research, Herlev and Gentofte Hospitals
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- TSH > 10
- Female
Exclusion Criteria:
- Competing serious disease
- Male
- Not able to understand written and spoken danish
- Pregnancy
- Thyroidectomized patients
- Amiodarone treatment.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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Hypothyroid patients
Hypothyroid patients treated with Levothyroxine as part of normal treatment.
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Normal treatment with levothyroxine.
Inne nazwy:
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Healthy volunteers
Matched on age and BMI.
18 Persons.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Changes in food intake at ad libitum meal
Ramy czasowe: 6 months
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Changes in food intake at ad libitum meal measured at each experimental day
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6 months
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Satiety
Ramy czasowe: 6 months
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Satiety measured on a visual analog score 13 times during each experimental day.
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6 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Changes in lean mass assessed through lean mass
Ramy czasowe: 6 months
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Changes in lean mass assessed through lean mass with DEXA-scan
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6 months
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Changes in fat mass assessed through lean mass with DEXA-scan
Ramy czasowe: 6 months
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Changes in lean mass assessed through lean mass with DEXA-scan
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6 months
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Changes in gall bladder emptying
Ramy czasowe: 6 months
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Changes in gall bladder emptying evaluated with ultrasound 6 times each experimental day before and after meal.
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6 months
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Changes in resting energy expenditure
Ramy czasowe: 6 months
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Changes in resting energy expenditure measured 3 times each experimental day using Indirect Calorimetry.
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6 months
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Changes in blood sugar response to standardized meal.
Ramy czasowe: 6 Months
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changes in blood sugar response to standardized meal measured before and after meal at each experimental day.
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6 Months
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Changes in stomach emptying
Ramy czasowe: 6 months
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Evaluated with continously measuring serum paracetamol after standardized meal containing 1,5 g paracetamol.
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6 months
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Changes in GIP hormones
Ramy czasowe: 6 months
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Continously measuring of a range of hormones during each experimental day: GIP
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6 months
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Changes in GLP-1 hormones
Ramy czasowe: 6 months
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Continously measuring of GLP-1 hormones during each experimental day
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6 months
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Changes in GLP-2 hormones
Ramy czasowe: 6 Months
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Continuously measuring of GLP-2 hormones during each experimental day
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6 Months
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Changes in PYY hormones
Ramy czasowe: 6 Months
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Continuously measuring of PYY hormones during each experimental day
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6 Months
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Changes in CCK hormones
Ramy czasowe: 6 Months
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Continuously measuring of CCK hormones during each experimental day
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6 Months
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Changes in Gastrin hormones
Ramy czasowe: 6 Months
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Continuously measuring of Gastrin during each experimental day
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6 Months
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Changes in Insulin hormones
Ramy czasowe: 6 Months
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Continuously measuring of Insulin during each experimental day
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6 Months
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Changes in Glucagon
Ramy czasowe: 6 Months
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Continuously measuring of Glucagon during each experimental day
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6 Months
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Changes in C-peptide
Ramy czasowe: 6 Months
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Continuously measuring of C-peptide during each experimental day
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6 Months
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Changes in Free-Fatty acids
Ramy czasowe: 6 Months
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Continuously measuring of Free Fatty acids during each experimental day
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6 Months
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Bjarke B Medici, MD, Department of Internal Medicine, Herlev and Gentofte hospitals.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Herlev-Gentofte Hypomafia
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
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