Insulin Resistance in Primary Hyperparathyroidism

Diabetes Clinical Trial

— IRIPH  

Official title:

Insulin Resistance in Primary Hyperparathyroidism, a Non-classical Manifestation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02711059
• Other study ID #: KarolinskaUH_pHPT_diabetes
• Status: Withdrawn
• Phase: N/A
• Start date: October 2015
• Est. completion date: June 2022

Study information

• Verified date: September 2020
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Treatment with insulin, sulfonylurea or metformin

Related Conditions & MeSH terms

• Diabetes
• Hypercalcemia
• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Insulin Resistance

Intervention

Procedure:
• parathyroidectomy
surgical treatment of hyperparathyroidism

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glucose tolerance test with estimation of insulin resistance	Homa IR	3 months
Primary	quality of life - self estimation protocol	EORTC QLQ-C30	3 months
Secondary	psychological wellbeing	POMS	3 months
Secondary	anxiety, depression	HAD	6 months
Secondary	cognition	MoCA-Test	6 months

External Links

•   Regional program