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Insulin Resistance in Primary Hyperparathyroidism (IRIPH)

Primary Purpose

Hyperparathyroidism, Diabetes, Hypercalcemia

Status
Withdrawn
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
parathyroidectomy
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperparathyroidism focused on measuring hyperparathyroidism, insulin resistance

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Treatment with insulin, sulfonylurea or metformin

Sites / Locations

  • Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

parathyroidectomy

control

Arm Description

change in insulin resistance

the study participant will be examined parallel with the active comparator

Outcomes

Primary Outcome Measures

glucose tolerance test with estimation of insulin resistance
Homa IR
quality of life - self estimation protocol
EORTC QLQ-C30

Secondary Outcome Measures

psychological wellbeing
POMS
anxiety, depression
HAD
cognition
MoCA-Test

Full Information

First Posted
October 18, 2015
Last Updated
September 6, 2020
Sponsor
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02711059
Brief Title
Insulin Resistance in Primary Hyperparathyroidism
Acronym
IRIPH
Official Title
Insulin Resistance in Primary Hyperparathyroidism, a Non-classical Manifestation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Why Stopped
studien skjuts på framtiden
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism, Diabetes, Hypercalcemia
Keywords
hyperparathyroidism, insulin resistance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
parathyroidectomy
Arm Type
Active Comparator
Arm Description
change in insulin resistance
Arm Title
control
Arm Type
No Intervention
Arm Description
the study participant will be examined parallel with the active comparator
Intervention Type
Procedure
Intervention Name(s)
parathyroidectomy
Other Intervention Name(s)
parathyroid adenomectomy
Intervention Description
surgical treatment of hyperparathyroidism
Primary Outcome Measure Information:
Title
glucose tolerance test with estimation of insulin resistance
Description
Homa IR
Time Frame
3 months
Title
quality of life - self estimation protocol
Description
EORTC QLQ-C30
Time Frame
3 months
Secondary Outcome Measure Information:
Title
psychological wellbeing
Description
POMS
Time Frame
3 months
Title
anxiety, depression
Description
HAD
Time Frame
6 months
Title
cognition
Description
MoCA-Test
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary hyperparathyroidism and fb-glukos>6,1 and/or HbA1c > 39 mmol/mol Exclusion Criteria: Treatment with insulin, sulfonylurea or metformin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inga-Lena Nilsson, MD, PhD
Organizational Affiliation
Karolinska Universitetssjukhuset
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
SE-17176
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24026893
Citation
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.
Results Reference
background
Links:
URL
http://www.viss.nu/Handlaggning/Vardprogram/Endokrina-organ/Prediabetes/
Description
Regional program

Learn more about this trial

Insulin Resistance in Primary Hyperparathyroidism

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