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Insulin Resistance in Primary Hyperparathyroidism (IRIPH)

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ClinicalTrials.gov Identifier: NCT02711059
Recruitment Status : Recruiting
First Posted : March 17, 2016
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Inga-Lena Nilsson, 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.

Condition or disease Intervention/treatment Phase
Hyperparathyroidism Diabetes Hypercalcemia Procedure: parathyroidectomy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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 : October 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022


Arm Intervention/treatment
Active Comparator: parathyroidectomy
change in insulin resistance
Procedure: parathyroidectomy
surgical treatment of hyperparathyroidism
Other Name: parathyroid adenomectomy

No Intervention: control
the study participant will be examined parallel with the active comparator



Primary Outcome Measures :
  1. glucose tolerance test with estimation of insulin resistance [ Time Frame: 3 months ]
    Homa IR

  2. quality of life - self estimation protocol [ Time Frame: 3 months ]
    EORTC QLQ-C30


Secondary Outcome Measures :
  1. psychological wellbeing [ Time Frame: 3 months ]
    POMS

  2. anxiety, depression [ Time Frame: 6 months ]
    HAD

  3. cognition [ Time Frame: 6 months ]
    MoCA-Test



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Treatment with insulin, sulfonylurea or metformin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02711059


Contacts
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Contact: Ylva Pernow, MD, PhD +46739789188 ylva.pernow@ki.se

Locations
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Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, SE-17176
Contact: Inga-Lena Nilsson, MD, PhD    +46702167535    inga-lena.nilsson@ki.se   
Contact: Rebecka Hallbeck, Res. ass.    +46725836757    rebecka.hallbeck@karolinska.se   
Sponsors and Collaborators
Karolinska University Hospital
Investigators
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Principal Investigator: Inga-Lena Nilsson, MD, PhD Karolinska Universitetssjukhuset

Additional Information:
Publications:
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Responsible Party: Inga-Lena Nilsson, MD, PhD, consultant surgeon, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02711059     History of Changes
Other Study ID Numbers: KarolinskaUH_pHPT_diabetes
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Inga-Lena Nilsson, Karolinska University Hospital:
hyperparathyroidism
insulin resistance

Additional relevant MeSH terms:
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Insulin Resistance
Hyperparathyroidism
Hyperparathyroidism, Primary
Hypercalcemia
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Parathyroid Diseases
Endocrine System Diseases
Calcium Metabolism Disorders
Water-Electrolyte Imbalance
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs