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

Study Overview

• Status: Completed
• Conditions: Hypothyroidism
• Intervention / Treatment: Drug: Levothyroxine

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 Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• Denmark
  • Region Hovedstaden
    • Copenhagen, Region Hovedstaden, Denmark, 2900
      • Center for Diabetes Research, Herlev and Gentofte Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

18 Hypothyroid female patients with a TSH > 10 without Levothyroxine treatment.

Description

Inclusion Criteria:

• TSH > 10
• Female

Exclusion Criteria:

• Competing serious disease
• Male
• Not able to understand written and spoken danish
• Pregnancy
• Thyroidectomized patients
• Amiodarone treatment.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hypothyroid patients; Hypothyroid patients treated with Levothyroxine as part of normal treatment.	Drug: Levothyroxine; Normal treatment with levothyroxine.; Other Names: Eltroxin/Euthyrox
Healthy volunteers; Matched on age and BMI. 18 Persons.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in food intake at ad libitum meal	Changes in food intake at ad libitum meal measured at each experimental day	6 months
Satiety	Satiety measured on a visual analog score 13 times during each experimental day.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in lean mass assessed through lean mass	Changes in lean mass assessed through lean mass with DEXA-scan	6 months
Changes in fat mass assessed through lean mass with DEXA-scan	Changes in lean mass assessed through lean mass with DEXA-scan	6 months
Changes in gall bladder emptying	Changes in gall bladder emptying evaluated with ultrasound 6 times each experimental day before and after meal.	6 months
Changes in resting energy expenditure	Changes in resting energy expenditure measured 3 times each experimental day using Indirect Calorimetry.	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.	6 Months
Changes in stomach emptying	Evaluated with continously measuring serum paracetamol after standardized meal containing 1,5 g paracetamol.	6 months
Changes in GIP hormones	Continously measuring of a range of hormones during each experimental day: GIP	6 months
Changes in GLP-1 hormones	Continously measuring of GLP-1 hormones during each experimental day	6 months
Changes in GLP-2 hormones	Continuously measuring of GLP-2 hormones during each experimental day	6 Months
Changes in PYY hormones	Continuously measuring of PYY hormones during each experimental day	6 Months
Changes in CCK hormones	Continuously measuring of CCK hormones during each experimental day	6 Months
Changes in Gastrin hormones	Continuously measuring of Gastrin during each experimental day	6 Months
Changes in Insulin hormones	Continuously measuring of Insulin during each experimental day	6 Months
Changes in Glucagon	Continuously measuring of Glucagon during each experimental day	6 Months
Changes in C-peptide	Continuously measuring of C-peptide during each experimental day	6 Months
Changes in Free-Fatty acids	Continuously measuring of Free Fatty acids during each experimental day	6 Months

Collaborators and Investigators

• Sponsor: Herlev Hospital
• Collaborators: Center for Diabetes Research, Herlev and Gentofte Hospital.
• Investigators: Principal Investigator: Bjarke B Medici, MD, Department of Internal Medicine, Herlev and Gentofte hospitals.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): August 30, 2018
• Study Completion (Actual): August 30, 2018

Study Registration Dates

• First Submitted: October 20, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (Estimate): December 15, 2016

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: November 5, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Body Composition; Food intake; Insulin response; Resting Energy Expenditure; Gall Bladder emptying
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hypothyroidism
• Other Study ID Numbers: Herlev-Gentofte Hypomafia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO