Insulin Resistance in Primary Hyperparathyroidism | NCT02711059

Studies
Insulin Resistance in Primary Hyperparathyroidism

NCT02711059

Sponsor

Karolinska University Hospital

Status

Withdrawn

Last Update Posted

Sep 9, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Hyperparathyroidism
Diabetes
Hypercalcemia

Interventions

parathyroidectomy

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

studien skjuts på framtiden

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Dec 2021Estimated

Completion Date

Jun 2022Estimated

First Submitted Date

Oct 18, 2015

First Submission Date that Met QC Criteria

Mar 11, 2016

First Posted Date

Mar 17, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2020

Last Update Posted Date

Sep 9, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Inga-Lena Nilsson, MD, PhD, consultant surgeon, Karolinska University HospitalPrincipal Investigator

Lead Sponsor

Karolinska University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
parathyroidectomy	Active Comparator	change in insulin resistance	Procedure: parathyroidectomy
control	No Intervention	the study participant will be examined parallel with the active comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
parathyroidectomy	Procedure	surgical treatment of hyperparathyroidism	parathyroidectomy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
psychological wellbeing	POMS	3 months
anxiety, depression	HAD	6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Inga-Lena Nilsson, MD, PhD	Karolinska University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska University Hospital		Stockholm		SE-17176	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24026893	Background	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.

ID	Term
D006961	Hyperparathyroidism
D003920	Diabetes Mellitus
D006934	Hypercalcemia
D007333	Insulin Resistance

ID	Term
D010279	Parathyroid Diseases
D004700	Endocrine System Diseases
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

ID	Term
D013507	Endocrine Surgical Procedures
D013514	Surgical Procedures, Operative