Insulin Resistance in Primary Hyperparathyroidism

NCT ID: NCT02711059

Last Updated: 2020-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hyperparathyroidism Diabetes Hypercalcemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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parathyroidectomy

change in insulin resistance

Group Type ACTIVE_COMPARATOR

parathyroidectomy

Intervention Type PROCEDURE

surgical treatment of hyperparathyroidism

control

the study participant will be examined parallel with the active comparator

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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parathyroidectomy

surgical treatment of hyperparathyroidism

Intervention Type PROCEDURE

Other Intervention Names

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parathyroid adenomectomy

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Treatment with insulin, sulfonylurea or metformin
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Inga-Lena Nilsson

MD, PhD, consultant surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Inga-Lena Nilsson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Universitetssjukhuset

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 24026893 (View on PubMed)

Related Links

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Other Identifiers

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KarolinskaUH_pHPT_diabetes

Identifier Type: -

Identifier Source: org_study_id

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