NCT02711059

Brief Summary

The aims of this study is to analyse if insulin resistance in primary hyperparathyroidism (pHPT) is normalised after parathyroid adenomectomy and if glucose tolerance test may be useful as a diagnostic tool by predicting potential improvement of insulin sensitivity after biochemical cure of pHPT.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

October 1, 2015

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

6.2 years

First QC Date

October 18, 2015

Last Update Submit

September 6, 2020

Conditions

HyperparathyroidismDiabetesHypercalcemia

Keywords

hyperparathyroidisminsulin resistance

Outcome Measures

Primary Outcomes (2)

  • glucose tolerance test with estimation of insulin resistance

    Homa IR

    3 months

  • quality of life - self estimation protocol

    EORTC QLQ-C30

    3 months

Secondary Outcomes (3)

  • psychological wellbeing

    3 months

  • anxiety, depression

    6 months

  • cognition

    6 months

Study Arms (2)

parathyroidectomy

ACTIVE COMPARATOR

change in insulin resistance

Procedure: parathyroidectomy

control

NO INTERVENTION

the study participant will be examined parallel with the active comparator

Interventions

parathyroidectomyPROCEDURE

surgical treatment of hyperparathyroidism

Also known as: parathyroid adenomectomy
parathyroidectomy

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary hyperparathyroidism and fb-glukos\>6,1 and/or HbA1c \> 39 mmol/mol

You may not qualify if:

  • Treatment with insulin, sulfonylurea or metformin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, SE-17176, Sweden

Location

Related Publications (1)

  • Norenstedt S, Pernow Y, Brismar K, Saaf M, Ekip A, Granath F, Zedenius J, Nilsson IL. Primary hyperparathyroidism and metabolic risk factors, impact of parathyroidectomy and vitamin D supplementation, and results of a randomized double-blind study. Eur J Endocrinol. 2013 Oct 21;169(6):795-804. doi: 10.1530/EJE-13-0547. Print 2013 Dec.

    PMID: 24026893BACKGROUND

Related Links

MeSH Terms

Conditions

HyperparathyroidismDiabetes MellitusHypercalcemiaInsulin Resistance

Interventions

Parathyroidectomy

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesCalcium Metabolism DisordersWater-Electrolyte ImbalanceHyperinsulinism

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Inga-Lena Nilsson, MD, PhD

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, consultant surgeon

Study Record Dates

First Submitted

October 18, 2015

First Posted

March 17, 2016

Study Start

October 1, 2015

Primary Completion

December 1, 2021

Study Completion

June 1, 2022

Last Updated

September 9, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)