Insulin Resistance in Primary Hyperparathyroidism (IRIPH)

September 6, 2020 updated by: Inga-Lena Nilsson, Karolinska University Hospital

Insulin Resistance in Primary Hyperparathyroidism, a Non-classical Manifestation

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, SE-17176
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Treatment with insulin, sulfonylurea or metformin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: parathyroidectomy
change in insulin resistance
Procedure: parathyroidectomy
surgical treatment of hyperparathyroidism
Other Names:
  • parathyroid adenomectomy
NO_INTERVENTION: control
the study participant will be examined parallel with the active comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glucose tolerance test with estimation of insulin resistance
Time Frame: 3 months
Homa IR
3 months
quality of life - self estimation protocol
Time Frame: 3 months
EORTC QLQ-C30
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
psychological wellbeing
Time Frame: 3 months
POMS
3 months
anxiety, depression
Time Frame: 6 months
HAD
6 months
cognition
Time Frame: 6 months
MoCA-Test
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Investigators

  • Principal Investigator: Inga-Lena Nilsson, MD, PhD, Karolinska Universitetssjukhuset

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

June 1, 2022

Study Registration Dates

First Submitted

October 18, 2015

First Submitted That Met QC Criteria

March 11, 2016

First Posted (ESTIMATE)

March 17, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 6, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KarolinskaUH_pHPT_diabetes

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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