QoL and Cognitive Function in Patients With Hypoparathyroidism
MR-hypoPT
Impaired Quality of Life and Cognitive Function in Patients With Hypoparathyroidism Might be Explained by Disturbed Capillary Flow Patterns in the Brain
2 other identifiers
observational
64
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedFirst Posted
Study publicly available on registry
September 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedDecember 23, 2021
December 1, 2021
1 year
September 2, 2019
December 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (8)
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.
- +3 more secondary outcomes
Study Arms (4)
Postsurgical hypoparathyroidism
Patients with hypoparathyroidism for 3 or more years after neck surgery
Non-surgical hypoparathyroidism
Patients with hypoparathyroidism for 3 or more years without neck surgery
Pseudohypoparathyroidism
Patients with the diagnosis of Pseudohypoparathyroidism
Healthy controls
25 controls from the background population matched on age (±3 years), gender and level of education with the 25 patients with postsurgical hypoparathyroidism
Interventions
Contrast-enhanced, magnetic resonance imaging (MRI) based method to detect disturbances in microvascular flow patterns in the human brain
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.
Eligibility Criteria
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.
You may qualify if:
- Patients:
- Male or female with age between 18 and 70 years.
- A low endogenous PTH production as verified by low plasma levels of intact PTH, necessitating treatment with 1-αhydroxylated vitamin D analogs.
- HypoPT for 3 years with continuous alphacalcidol or calcitriol treatment prior to study entry (except for the patients with PHP).
- In case of thyroid disease, TSH within reference range within the last year
- Speaks and reads Danish
- Controls:
- Male or female with age between 18 and 80 years.
- No known diseases in the calcium homeostasis
- Speaks and reads Danish
You may not qualify if:
- Reduced kidney function (eGFR \< 30 mL/min/1.73m2).
- Diabetes type 1 or 2
- History of hypertension for more than two years (treated or untreated)
- Clinical suspicion of major depression (also if treated)
- Clinical suspicion of alcohol-related dementia
- Other organic or psychiatric cause the patients symptoms
- Contraindications to contrast-enhanced MRI.
- Metal implants close to the head, which will interfere with the MRI or pacemaker. The patients will complete a metal scheme.
- Claustrophobia
- Unwillingness to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinic for Osteoporosis, Aarhus University Hospital
Aarhus N, Jutland, 8200, Denmark
Related Publications (56)
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Biospecimen
Plasma, serum and 24hr urine samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tanja T Sikjær, MD, PhD
Department of Endocrinology and Internal Medicine, Aarhus University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, MD, PhD
Study Record Dates
First Submitted
September 2, 2019
First Posted
September 30, 2020
Study Start
October 1, 2019
Primary Completion
October 1, 2020
Study Completion
December 1, 2021
Last Updated
December 23, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share