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Hypothyroidism, Metabolism and Food Intake (Hypomafia)

5. november 2018 oppdatert av: Bjarke Borregaard Medici, Herlev Hospital

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

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

18

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

Inclusion Criteria:

  • TSH > 10
  • Female

Exclusion Criteria:

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Hypothyroid patients
Hypothyroid patients treated with Levothyroxine as part of normal treatment.
Normal treatment with levothyroxine.
Andre navn:
  • Eltroxin/Euthyrox
Healthy volunteers
Matched on age and BMI. 18 Persons.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in food intake at ad libitum meal
Tidsramme: 6 months
Changes in food intake at ad libitum meal measured at each experimental day
6 months
Satiety
Tidsramme: 6 months
Satiety measured on a visual analog score 13 times during each experimental day.
6 months

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Etterforskere

  • Hovedetterforsker: Bjarke B Medici, MD, Department of Internal Medicine, Herlev and Gentofte hospitals.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2015

Primær fullføring (Faktiske)

30. august 2018

Studiet fullført (Faktiske)

30. august 2018

Datoer for studieregistrering

Først innsendt

20. oktober 2016

Først innsendt som oppfylte QC-kriteriene

14. desember 2016

Først lagt ut (Anslag)

15. desember 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. november 2018

Sist bekreftet

1. november 2018

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • Herlev-Gentofte Hypomafia

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Levothyroxine

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