CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 64 enrolled
Drug / intervention
MRI scans +4 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04569604
NCT04569604N/ACompleted

Impaired Quality of Life and Cognitive Function in Patients With Hypoparathyroidism Might be Explained by Disturbed Capillary Flow Patterns in the Brain

University of Aarhus·observational·Posted Sep 30, 2020·Updated Dec 23, 2021

In Brief

An observational study evaluating MRI scans, Neuro cognitive tests, and 3 other interventions for Hypoparathyroidism and Pseudo Hypoparathyroidism. Completed, enrolled 64 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesDenmark
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 30, 2020
Enrollment StartOct 1, 2019
Primary CompletionOct 1, 2020
Study CompletionDec 1, 2021
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 5.8 years ago

Interventions

MRI scansother

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

Neuro cognitive testsother

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

Questionnaires on Quality of Lifeother

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

Blood samplesother

Markers of calcium homeostasis, inflammatory markers and hematology.

24 hr urine samplesother

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