Center for Diabetes Research, Herlev and Gentofte Hospitals
Copenhagen, Capital Region, 2900, Denmark
NCT Number: NCT02993562
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
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Notify Me20 year–75 year
Female
Observational
Copenhagen, Capital Region, 2900, Denmark
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,
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Normal treatment with levothyroxine.
Other names: Eltroxin/Euthyrox
Time frame: 6 months
Changes in food intake at ad libitum meal measured at each experimental day
Time frame: 6 months
Satiety measured on a visual analog score 13 times during each experimental day.
Time frame: 6 months
Changes in lean mass assessed through lean mass with DEXA-scan
Time frame: 6 months
Changes in lean mass assessed through lean mass with DEXA-scan
Time frame: 6 months
Changes in gall bladder emptying evaluated with ultrasound 6 times each experimental day before and after meal.
Time frame: 6 months
Changes in resting energy expenditure measured 3 times each experimental day using Indirect Calorimetry.
Time frame: 6 Months
changes in blood sugar response to standardized meal measured before and after meal at each experimental day.
Time frame: 6 months
Evaluated with continously measuring serum paracetamol after standardized meal containing 1,5 g paracetamol.
Time frame: 6 months
Continously measuring of a range of hormones during each experimental day: GIP
Time frame: 6 months
Continously measuring of GLP-1 hormones during each experimental day
Time frame: 6 Months
Continuously measuring of GLP-2 hormones during each experimental day
Time frame: 6 Months
Continuously measuring of PYY hormones during each experimental day
Time frame: 6 Months
Continuously measuring of CCK hormones during each experimental day
Time frame: 6 Months
Continuously measuring of Gastrin during each experimental day
Time frame: 6 Months
Continuously measuring of Insulin during each experimental day
Time frame: 6 Months
Continuously measuring of Glucagon during each experimental day
Time frame: 6 Months
Continuously measuring of C-peptide during each experimental day
Time frame: 6 Months
Continuously measuring of Free Fatty acids during each experimental day
Herlev Hospital
Other
Levothyroxine Substitution Therapy in Hypothyroid Patients - Impact on Appetite and Food Intake
Acronym: Hypomafia
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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