MR-hypoPT
Impaired Quality of Life and Cognitive Function in Patients With Hypoparathyroidism Might be Explained by Disturbed Capillary Flow Patterns in the Brain
Sponsor study identifier
Secondary identifiers
OTHER · Ethical Committee of The Central Denmark Region
observational
64
1 country
1
Study Start
October 1, 2019
Actual (reported)Primary Completion
October 1, 2020
Actual (reported)Study Completion
December 1, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2, 2019
Actual (reported)October 1, 2019
Actual (reported)September 30, 2020
Actual (reported)October 1, 2020
Actual (reported)December 1, 2021
Actual (reported)Capillary transit time heterogeneity
Capillary transit time heterogeneity is measured by MRI scans
MRI scan performed at baseline, no follow-up up. It takes 1 hour to perform
Index 1: Processing speed
Neuropsychological tests are performed immediately before or immediately after the MRI scan and scheduled to take 1½ hours.
Index 2: Working memory
Neuropsychological tests are performed immediately before or immediately after the MRI scan and scheduled to take 1½ hours.
Index 3: Executive function
Neuropsychological tests are performed immediately before or immediately after the MRI scan and scheduled to take 1½ hours.
Index 4: Verbal learning and memory
Neuropsychological tests are performed immediately before or immediately after the MRI scan and scheduled to take 1½ hours.
Index 5: Visual learning and memory
Neuropsychological tests are performed immediately before or immediately after the MRI scan and scheduled to take 1½ hours.
Patients with hypoparathyroidism for 3 or more years after neck surgery
Patients with hypoparathyroidism for 3 or more years without neck surgery
Contrast-enhanced, magnetic resonance imaging (MRI) based method to detect disturbances in microvascular flow patterns in the human brain
The patients with postsurgical, non-surgical and pseudo hypoparathyroidism will be invited from our outpatient clinic to participate in the study. The healthy controls will be randomly recruited from the background population by an extract from the CPR register and an invitation to participate in the study will be send by electronic letter.
Clinic for Osteoporosis, Aarhus University Hospital
Aarhus N, Jutland, 8200, Denmark
Underbjerg L, Sikjaer T, Mosekilde L, Rejnmark L. Cardiovascular and renal complications to postsurgical hypoparathyroidism: a Danish nationwide controlled historic follow-up study. J Bone Miner Res. 2013 Nov;28(11):2277-85. doi: 10.1002/jbmr.1979.
Underbjerg L, Sikjaer T, Mosekilde L, Rejnmark L. The Epidemiology of Nonsurgical Hypoparathyroidism in Denmark: A Nationwide Case Finding Study. J Bone Miner Res. 2015 Sep;30(9):1738-44. doi: 10.1002/jbmr.2501. Epub 2015 May 31.
Plasma, serum and 24hr urine samples
Tanja T Sikjær, MD, PhD
Department of Endocrinology and Internal Medicine, Aarhus University Hospital
64 participants (actual enrollment reported by the registry).
First Submitted
September 2, 2019
First Posted
September 30, 2020
Study Start
October 1, 2019
Actual (reported)Patients with the diagnosis of Pseudohypoparathyroidism
25 controls from the background population matched on age (±3 years), gender and level of education with the 25 patients with postsurgical hypoparathyroidism
Standard neuropsychological test battery consists of validated tests to assess cognitive domains including verbal and visual memory, attention, language, visuospatial and executive functioning.
SF36v2, WHO-5 well-being index, HPQ28, Symptom questionnaire, and a general questionnaire on background information, medication and diet.
Markers of calcium homeostasis, inflammatory markers and hematology.
24 hr urine content of calcium, phosphate, magnesium, and creatinine.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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Primary Completion
October 1, 2020
Actual (reported)Study Completion
December 1, 2021
Actual (reported)Last Updated
December 23, 2021
Record last verified: 2021-12
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