Insulin Resistance in Primary Hyperparathyroidism

Not Applicable

Withdrawn

• Conditions: Hypercalcemia; Hyperparathyroidism; Diabetes

• Registration Number: NCT02711059
• Lead Sponsor: Karolinska University Hospital

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-18
• Study First Submitted QC: 2016-03-11
• Study First Posted: 2016-03-17
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-06
• Last Update Posted: 2020-09-09
• Primary Completion: 2021-12
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• Treatment with insulin, sulfonylurea or metformin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
anxiety, depression	6 months	HAD
psychological wellbeing	3 months	POMS
cognition	6 months	MoCA-Test

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden