Clinical Trial: Hypothyroidism, Metabolism and Food Intake

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief 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

Detailed Summary:

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 analys
Sponsor: Herlev Hospital

Current Primary Outcome:

• 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
• Satiety [ Time Frame: 6 months ]
  Satiety measured on a visual analog score 13 times during each experimental day.

Original Primary Outcome: Same as current

Current Secondary Outcome:

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

Original Secondary Outcome: Same as current

Information By: Herlev Hospital

Dates:
Date Received: October 20, 2016
Date Started: August 2015
Date Completion: June 2017
Last Updated: December 14, 2016
Last Verified: December 2016