Hypothyroidism, Metabolism and Food Intake

Hypothyroidism Clinical Trial

— Hypomafia  

Official title:

Levothyroxine Substitution Therapy in Hypothyroid Patients - Impact on Appetite and Food Intake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993562
• Other study ID #: Herlev-Gentofte Hypomafia
• Status: Completed
• Start date: August 2015
• Est. completion date: August 30, 2018

Study information

• Verified date: November 2018
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• TSH > 10

• Female

Exclusion Criteria:

• Competing serious disease

• Male

• Not able to understand written and spoken danish

• Pregnancy

• Thyroidectomized patients

• Amiodarone treatment.

Related Conditions & MeSH terms

• Hypothyroidism

Intervention

Drug:
• Levothyroxine
Normal treatment with levothyroxine.

Locations

Country	Name	City	State
Denmark	Center for Diabetes Research, Herlev and Gentofte Hospitals	Copenhagen	Region Hovedstaden

Sponsors (2)

Lead Sponsor	Collaborator
Herlev Hospital	Center for Diabetes Research, Herlev and Gentofte Hospital.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in food intake at ad libitum meal	Changes in food intake at ad libitum meal measured at each experimental day	6 months
Primary	Satiety	Satiety measured on a visual analog score 13 times during each experimental day.	6 months
Secondary	Changes in lean mass assessed through lean mass	Changes in lean mass assessed through lean mass with DEXA-scan	6 months
Secondary	Changes in fat mass assessed through lean mass with DEXA-scan	Changes in lean mass assessed through lean mass with DEXA-scan	6 months
Secondary	Changes in gall bladder emptying	Changes in gall bladder emptying evaluated with ultrasound 6 times each experimental day before and after meal.	6 months
Secondary	Changes in resting energy expenditure	Changes in resting energy expenditure measured 3 times each experimental day using Indirect Calorimetry.	6 months
Secondary	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.	6 Months
Secondary	Changes in stomach emptying	Evaluated with continously measuring serum paracetamol after standardized meal containing 1,5 g paracetamol.	6 months
Secondary	Changes in GIP hormones	Continously measuring of a range of hormones during each experimental day: GIP	6 months
Secondary	Changes in GLP-1 hormones	Continously measuring of GLP-1 hormones during each experimental day	6 months
Secondary	Changes in GLP-2 hormones	Continuously measuring of GLP-2 hormones during each experimental day	6 Months
Secondary	Changes in PYY hormones	Continuously measuring of PYY hormones during each experimental day	6 Months
Secondary	Changes in CCK hormones	Continuously measuring of CCK hormones during each experimental day	6 Months
Secondary	Changes in Gastrin hormones	Continuously measuring of Gastrin during each experimental day	6 Months
Secondary	Changes in Insulin hormones	Continuously measuring of Insulin during each experimental day	6 Months
Secondary	Changes in Glucagon	Continuously measuring of Glucagon during each experimental day	6 Months
Secondary	Changes in C-peptide	Continuously measuring of C-peptide during each experimental day	6 Months
Secondary	Changes in Free-Fatty acids	Continuously measuring of Free Fatty acids during each experimental day	6 Months