Growth Hormone, IGF-1 and Medical Treatment in Acromegaly: Are There Effects on Gut Hormone Physiology and Postprandial Substrate Metabolism?
NCT02152124
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- 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
- 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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Descriptive Information | ||||
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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:
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 |
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Publications * |
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* 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 | 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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | University Hospital, Ghent | |||
Verification Date | December 2016 |