QoL and Cognitive Function in Patients With Hypoparathyroidism

NCT04569604 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2021-12-23

No results posted yet for this study

Summary

Hypoparathyroidism (HypoPT) is a disease with inadequate production of parathyroid hormone (PTH) from the parathyroid glands leading to hypocalcemia. The most common form is postsurgical HypoPT due to neck surgery resulting in removed or damaged parathyroid glands.

HypoPT is a complex disease with a reduced Quality of life, mild cognitive impairment and in some patients have brain calcifications.

The aim of the present study is to investigate the cognitive function in patients with postsurgical and non-surgical (HypoPT) by neuropsychological assessments and magnetic resonance imaging (MRI).

The investigators will apply a contrast-enhanced MRI based method to HypoPT patients and age- and gender matched controls to examine whether capillary dysfunction can be detected, and whether symptom severity across patients correlates with the degree of capillary dysfunction in certain brain regions. To our knowledge there have been no previous studies on cognitive impairment and its origin in patients with HypoPT. The investigators hypothesize that the symptoms of HypoPT patients represent various degrees of capillary dysfunction, which interfere with their brain function.

Conditions

  • Hypoparathyroidism
  • Pseudo Hypoparathyroidism

Interventions

DIAGNOSTIC_TEST

MRI scans

Contrast-enhanced, magnetic resonance imaging (MRI) based method to detect disturbances in microvascular flow patterns in the human brain

DIAGNOSTIC_TEST

Neuro cognitive tests

Standard neuropsychological test battery consists of validated tests to assess cognitive domains including verbal and visual memory, attention, language, visuospatial and executive functioning.

DIAGNOSTIC_TEST

Questionnaires on Quality of Life

SF36v2, WHO-5 well-being index, HPQ28, Symptom questionnaire, and a general questionnaire on background information, medication and diet.

DIAGNOSTIC_TEST

Blood samples

Markers of calcium homeostasis, inflammatory markers and hematology.

DIAGNOSTIC_TEST

24 hr urine samples

24 hr urine content of calcium, phosphate, magnesium, and creatinine.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Tanja T Sikjær, MD, PhD · Department of Endocrinology and Internal Medicine, Aarhus University Hospital

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2020-10-01
Completion
2021-12-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04569604 on ClinicalTrials.gov