IRIPH: Insulin Resistance in Primary Hyperparathyroidism

Sponsor

Karolinska University Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02711059

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperparathyroidism Diabetes Hypercalcemia	Procedure: parathyroidectomy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Insulin Resistance in Primary Hyperparathyroidism, a Non-classical Manifestation

Study Start Date :

Oct 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

glucose tolerance test with estimation of insulin resistance [3 months]
Homa IR
quality of life - self estimation protocol [3 months]
EORTC QLQ-C30

Secondary Outcome Measures

psychological wellbeing [3 months]
POMS
anxiety, depression [6 months]
HAD
cognition [6 months]
MoCA-Test

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska University Hospital	Stockholm		Sweden	SE-17176

Sponsors and Collaborators

Karolinska University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Regional program

Publications

Norenstedt S, Pernow Y, Brismar K, Sääf 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.

Responsible Party:

Inga-Lena Nilsson, MD, PhD, consultant surgeon, Karolinska University Hospital

ClinicalTrials.gov Identifier:

NCT02711059

Other Study ID Numbers:

KarolinskaUH_pHPT_diabetes

First Posted:

Mar 17, 2016

Last Update Posted:

Sep 9, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Inga-Lena Nilsson, MD, PhD, consultant surgeon, Karolinska University Hospital

hyperparathyroidism

insulin resistance

Additional relevant MeSH terms:

Insulin Resistance

Hypercalcemia

Hyperparathyroidism

Hyperparathyroidism, Primary

Parathyroid Hormone

Study Results

No Results Posted as of Sep 9, 2020