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Completed

NCT Number: NCT02993562

Hypothyroidism, Metabolism 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

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Key information

Age range

20 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Center for Diabetes Research, Herlev and Gentofte Hospitals

Copenhagen, Capital Region, 2900, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • TSH > 10
  • Female

Exclusion criteria

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

Treatment and study plan

Levothyroxine

Drug

Normal treatment with levothyroxine.

Other names: Eltroxin/Euthyrox

Primary outcomes

  1. Changes in food intake at ad libitum meal

    Time frame: 6 months

    Changes in food intake at ad libitum meal measured at each experimental day

  2. Satiety

    Time frame: 6 months

    Satiety measured on a visual analog score 13 times during each experimental day.

Secondary outcomes

  1. Changes in lean mass assessed through lean mass

    Time frame: 6 months

    Changes in lean mass assessed through lean mass with DEXA-scan

  2. Changes in fat mass assessed through lean mass with DEXA-scan

    Time frame: 6 months

    Changes in lean mass assessed through lean mass with DEXA-scan

  3. Changes in gall bladder emptying

    Time frame: 6 months

    Changes in gall bladder emptying evaluated with ultrasound 6 times each experimental day before and after meal.

  4. Changes in resting energy expenditure

    Time frame: 6 months

    Changes in resting energy expenditure measured 3 times each experimental day using Indirect Calorimetry.

  5. Changes in blood sugar response to standardized meal.

    Time frame: 6 Months

    changes in blood sugar response to standardized meal measured before and after meal at each experimental day.

  6. Changes in stomach emptying

    Time frame: 6 months

    Evaluated with continously measuring serum paracetamol after standardized meal containing 1,5 g paracetamol.

  7. Changes in GIP hormones

    Time frame: 6 months

    Continously measuring of a range of hormones during each experimental day: GIP

  8. Changes in GLP-1 hormones

    Time frame: 6 months

    Continously measuring of GLP-1 hormones during each experimental day

  9. Changes in GLP-2 hormones

    Time frame: 6 Months

    Continuously measuring of GLP-2 hormones during each experimental day

  10. Changes in PYY hormones

    Time frame: 6 Months

    Continuously measuring of PYY hormones during each experimental day

  11. Changes in CCK hormones

    Time frame: 6 Months

    Continuously measuring of CCK hormones during each experimental day

  12. Changes in Gastrin hormones

    Time frame: 6 Months

    Continuously measuring of Gastrin during each experimental day

  13. Changes in Insulin hormones

    Time frame: 6 Months

    Continuously measuring of Insulin during each experimental day

  14. Changes in Glucagon

    Time frame: 6 Months

    Continuously measuring of Glucagon during each experimental day

  15. Changes in C-peptide

    Time frame: 6 Months

    Continuously measuring of C-peptide during each experimental day

  16. Changes in Free-Fatty acids

    Time frame: 6 Months

    Continuously measuring of Free Fatty acids during each experimental day

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Collaborators

  • Center for Diabetes Research, Herlev and Gentofte Hospital.

Registry information

Official study title

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

Acronym: Hypomafia

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 15, 2016
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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