ClinicalTrials.gg
WithdrawnNCT02711059IRIPHUpdated Sep 9, 2020

Insulin Resistance in Primary Hyperparathyroidism

An interventional study of parathyroidectomy in Hyperparathyroidism, Diabetes and Hypercalcemia, sponsored by Karolinska University Hospital. Withdrawn at 1 site in Sweden. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2020-09-09.

Sponsored by Karolinska University Hospital · Not applicable, Interventional, and Basic science

Why this study was withdrawn
studien skjuts på framtiden
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

Read the detailed description

To be conducted at the Karolinska University Hospital, Stockholm. Patients with fb-glucos >6.1 and HbA1c without medical treatment will be included after informed consent and randomised to parathyroidectomy (PTX) within three months or not. The groups will be examined 4 ±4 weeks before and 12±2 weeks after PTX, similar for the control group. The number of participants will be estimated by power calculations based on a pilot study including 20 patients.

The test protocol includes glucose load with control of glucose and insulin, (0, 30, 60 and 120 min) together with measurement of markers of oxidative stress and inflammation.

02

Conditions studied

  • Hyperparathyroidism
  • Diabetes
  • Hypercalcemia

Keywords

  • hyperparathyroidism
  • insulin resistance
03

In context

Hyperparathyroidism

110 studies on the registry are indexed under Hyperparathyroidism; 12 are open to participants now.

Browse Hyperparathyroidism studies →

Lead sponsor

Karolinska University Hospital is the lead sponsor of 279 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Treatment with insulin, sulfonylurea or metformin
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    parathyroidectomy

    change in insulin resistance

    Procedure: parathyroidectomy

  • No intervention
    control

    the study participant will be examined parallel with the active comparator

Interventions

  • Procedureparathyroidectomy

    surgical treatment of hyperparathyroidism

    Also known as: parathyroid adenomectomy

06

What researchers measure

Primary outcomes

  1. glucose tolerance test with estimation of insulin resistance

    Homa IR

    Time frame: 3 months

  2. quality of life - self estimation protocol

    EORTC QLQ-C30

    Time frame: 3 months

Secondary outcomes

  1. psychological wellbeing

    POMS

    Time frame: 3 months

  2. anxiety, depression

    HAD

    Time frame: 6 months

  3. cognition

    MoCA-Test

    Time frame: 6 months

07

Study locations

1 site
  • Karolinska University Hospital
    Stockholm, SE-17176, Sweden
08

References and documents

Publications

  • 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. PubMed 24026893 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02711059
Responsible party
Inga-Lena Nilsson (MD, PhD, consultant surgeon, Karolinska University Hospital) — Principal investigator
First posted
Mar 17, 2016
Start date
Oct 2015
Primary completion
Dec 2021 (estimated)
Completion
Jun 2022 (estimated)
Last update
Sep 9, 2020

Study contacts

Inga-Lena Nilsson, MD, PhD
principal investigator · Karolinska Universitetssjukhuset

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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