Clinical trial · Observational
A Prospective Study of Outcome After Therapy for Acromegaly
NCT01809808CI-TRIAL-00094120completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate hormone values and other markers of disease activity in a cohort of patients with acromegaly at the time of diagnosis and then prospectively after surgical or other treatment. This study is designed to determine blood levels of growth hormone and related hormones and cardiovascular risk markers as well as signs and symptoms of the disease at diagnosis and how these parameters change over time after surgical or other therapy. The investigators will also obtain hormonal data in a group of 50 healthy subjects who will each be studied just once with an oral glucose tolerance test (OGTT). These data will provide a comparison group to the acromegaly subjects.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acromegaly | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adipose Tissue Biopsy | Procedure | — | UNRESOLVED |
| Medications for acromegaly | Drug | — | UNRESOLVED |
| Surgery for acromegaly | Procedure | — | UNRESOLVED |
| Total body magnetic resonance imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Acromegaly Subjects
- description
- People who have a biochemical diagnosis of acromegaly, and will or have already undergone surgery for acromegaly and will be taking medications for acromegaly . Subjects will undergo blood sampling, metabolic rate measurement, adipose tissue biopsy and total body magnetic resonance imaging before and over time after either surgery or medical therapy for acromegaly.
- interventionNames
- Procedure: Surgery for acromegaly
- Drug: Medications for acromegaly
- Diagnostic Test: Total body magnetic resonance imaging
- Procedure: Adipose Tissue Biopsy
- label
- Healthy Subjects
- description
- People who are not diagnosed with acromegaly, responding to flyer or by word of mouth for participation, without medical problems, not taking medications, and with a stable weight for 3 months prior to study. Subjects will undergo blood sampling, total body MRI and adipose tissue biopsy once.
- interventionNames
- Diagnostic Test: Total body magnetic resonance imaging
- Procedure: Adipose Tissue Biopsy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Acromegaly Subjects Inclusion Criteria: * Adult males and females. * Ages 18 and over. * Presenting to the PI or one of the sub-investigators for evaluation of acromegaly. * Must have a biochemical diagnosis of acromegaly consisting of an elevated serum insulin-like growth factor 1 (IGF-1) level. Supportive although not required for entry are an elevated growth hormone (GH) level and a failure of GH to suppress normally after oral glucose administration. * Willingness to participate in this study's procedures. Exclusion Criteria: * Subjects who are unwilling to comply with the procedures outlined in the study. * Subjects who do not have the ability to fully comprehend the nature of the study, to follow instructions, and/or cooperate with study procedures * Are unwilling to provide informed consent to participate in the study. Healthy Subjects Inclusion Criteria: * Adult males and females. * Ages 18 and over. * Responding to ads for participation or by word of mount. * No medical problems, no medications, stable weight for 3 months prior to study. * Willingness to participate in this study's procedures. Exclusion Criteria: * Subjects who are unwilling to comply with the procedures outlined in the study. * Subjects who do not have the ability to fully comprehend the nature of the study, to follow instructions, and/or cooperate with study procedures * Are unwilling to provide informed consent to participate in the study. * Failure to meet the inclusion criteria.
References
Publications (3)
- DERIVEDFreda PU, Reyes-Vidal C, Jin Z, Pugh M, Panigrahi SK, Bruce JN, Wardlaw SL. Plasma Agouti-Related Protein Levels in Acromegaly and Effects of Surgical or Pegvisomant Therapy. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5453-5461. doi: 10.1210/jc.2019-01079. PMID 31361303
- DERIVEDReyes-Vidal CM, Mojahed H, Shen W, Jin Z, Arias-Mendoza F, Fernandez JC, Gallagher D, Bruce JN, Post KD, Freda PU. Adipose Tissue Redistribution and Ectopic Lipid Deposition in Active Acromegaly and Effects of Surgical Treatment. J Clin Endocrinol Metab. 2015 Aug;100(8):2946-55. doi: 10.1210/jc.2015-1917. Epub 2015 Jun 2. PMID 26037515
- DERIVEDReyes-Vidal C, Fernandez JC, Bruce JN, Crisman C, Conwell IM, Kostadinov J, Geer EB, Post KD, Freda PU. Prospective study of surgical treatment of acromegaly: effects on ghrelin, weight, adiposity, and markers of CV risk. J Clin Endocrinol Metab. 2014 Nov;99(11):4124-32. doi: 10.1210/jc.2014-2259. Epub 2014 Aug 19. PMID 25137427