Growth Hormone, IGF-1 and Medical Treatment in Acromegaly: Are There Effects on Gut Hormone Physiology and Postprandial Substrate Metabolism?

NCT02152124

Last updated date
Study Location
Ghent University Hospital, Department of Endocrinology, 9K12IE
Ghent, , 9000, Belgium
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acromegaly
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of acromegaly over 1 year ago, no changes in treatment schedule since at least 6 months (groups 1-3 and 5) OR healthy volunteer without diagnosis of acromegaly (group 4)

- Patient is willing to participate and has signed the informed consent

- Age > 18 years and < 80 years

- Body Mass Index 18-40 kg/m²

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Biochemistry: liver function tests > 3x ULN; HbA1C > 58 mmol/mol


- All untreated endocrine disorders including uncontrolled diabetes mellitus type 2
(i.e. HbA1C > 58 mmol/mol)


- Bariatric surgery; malabsorptive syndromes; hepatic or renal failure


- Current medication use: insulin, metformin, sulfonylurea, fibrates, incretin mimetics,
dopamine agonists (for all but insulin, participation is allowed after a 2- week
wash-out period)


- Abuse of alcohol or drugs


- Weight changes > 10% of body weight during preceding 12 months

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Advanced Information
Descriptive Information
Brief Title Growth Hormone, IGF-1 and Medical Treatment in Acromegaly: Are There Effects on Gut Hormone Physiology and Postprandial Substrate Metabolism?
Official Title Growth Hormone, IGF-1 and Medical Treatment in Acromegaly: Are There Effects on Gut Hormone Physiology and Postprandial Substrate Metabolism?
Brief Summary

Acromegaly is a rare hormonal disorder leading to increased morbidity and mortality. In the vast majority of cases, a pituitary somatotroph cell adenoma causes excess growth hormone (GH) secretion, leading to hepatic insulin-like-growth factor 1 (IGF-1) hypersecretion. Both the disease as well as its treatment with long-acting somatostatin analogs (LA-SMSA) and/or pegvisomant affect glucose and lipid metabolism, possibly contributing to increased cardiovascular risk.

In this pilot study, the investigators want to explore insulin sensitivity, postprandial gut hormone response, lipid handling and adipocytokine profile in the following 4 groups:

  • controlled acromegalic patients on LA-SMSA (group 1)
  • controlled acromegalic patients on combination treatment of LA-SMSA and pegvisomant (group 2)
  • acromegalic patients without need for medical therapy after surgery (group 3)
  • healthy control subjects (group 4)

Furthermore, a longitudinal exploration will be performed in uncontrolled acromegalic patients (i.e. patients with serum IGF-1 levels above age-specific thresholds and/or symptoms due to active acromegaly (excessive sweating , arthralgia)) on LA-SMSA monotherapy (group 5). In this group, insulin sensitivity, postprandial gut hormone response, lipid handling and adipocytokine profile will be explored before introducing pegvisomant and three months after normalisation of IGF-1 levels.

The investigators hypothesize that lipid and glucose handling will be less efficient in the controlled acromegalic patients on LA-SMSA than in controlled patients on combination therapy or after surgery, and that there will be no difference in substrate metabolism between healthy controls and controlled acromegalic patients on combination treatment or after surgery. Further, they hypothesize that introducing pegvisomant in uncontrolled acromegalic patients will improve their postprandial lipid and glucose handling.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum
Sampling Method Non-Probability Sample
Study Population Groups 1-3 and 5: outpatient clinic attendants Group 4: recruted from community (by placard)
Condition Acromegaly
Intervention Not Provided
Study Groups/Cohorts
  • Controlled on LA-SMSA
    Patients with controlled acromegaly on long-acting somatostatin analogs
  • Controlled on LA-SMSA and pegvisomant
    Patients with controlled acromegaly on long-acting somatostatin analogs and pegvisomant
  • Controlled after surgery
    Controlled acromegaly patients without need for medical therapy after surgery
  • Healhy controls
    Healthy volunteers
  • Uncontrolled on LA-SMSA
    Patients with uncontrolled acromegaly (i.e. with serum IGF-1 levels above age-specific thresholds and/or symptoms due to active acromegaly (e.g. excessive sweating, arthralgia)) on LA-SMSA monotherapy in maximal dosage
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 28, 2014)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2017
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of acromegaly over 1 year ago, no changes in treatment schedule since at least 6 months (groups 1-3 and 5) OR healthy volunteer without diagnosis of acromegaly (group 4)
  • Patient is willing to participate and has signed the informed consent
  • Age > 18 years and < 80 years
  • Body Mass Index 18-40 kg/m²

Exclusion Criteria:

  • Biochemistry: liver function tests > 3x ULN; HbA1C > 58 mmol/mol
  • All untreated endocrine disorders including uncontrolled diabetes mellitus type 2 (i.e. HbA1C > 58 mmol/mol)
  • Bariatric surgery; malabsorptive syndromes; hepatic or renal failure
  • Current medication use: insulin, metformin, sulfonylurea, fibrates, incretin mimetics, dopamine agonists (for all but insulin, participation is allowed after a 2- week wash-out period)
  • Abuse of alcohol or drugs
  • Weight changes > 10% of body weight during preceding 12 months
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT02152124
Other Study ID Numbers EC/2013/857
WI182140 ( Other Grant/Funding Number: Pfizer )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Ghent
Study Sponsor University Hospital, Ghent
Collaborators Pfizer
Investigators
Principal Investigator:Guy T'Sjoen, MD, PhDUniversity Hospital, Ghent
PRS Account University Hospital, Ghent
Verification Date December 2016