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| Name | Class |
|---|---|
| Ipsen | INDUSTRY |
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This study investigates fat distribution in people with acromegaly. The investigator is also investigating the change of fat distribution before and after treatment of acromegaly. The investigator will compare the results of people with acromegaly to the results of healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Acromegaly | All study subjects with acromegaly will be studied twice - once during the active stage of their disease (pre-treatment) and a second time: 3 months after treatment of acromegaly. Controls will be studied at one time point. | ||
| Healthy controls |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Liver Fat | Change in intrahepatic fat after biochemical control of acromegaly | Baseline and 3-month follow-up visit |
| Change in Thigh Muscle Cross-sectional Area | Change in thigh muscle cross-sectional area after biochemical control of acromegaly | Baseline and 3-month follow-up visit |
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Inclusion Criteria:
Exclusion Criteria:
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Thirty-two study subjects will be studied: 1) patients with active acromegaly, and 2) healthy controls. Study subjects with acromegaly will be prescribed treatment for acromegaly by their healthcare providers, and this study will not interfere in anyway with clinical care and will not provide surgery, medications or other forms of clinical care.
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| Name | Affiliation | Role |
|---|---|---|
| Karen Miller, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Acromegaly | All study subjects with acromegaly will be studied twice - once during the active stage of their disease (pre-treatment) and a second time: 3 months after treatment of acromegaly. Controls will be studied at one time point. |
| FG001 | Healthy Controls | Healthy, matched controls completed a baseline visit only |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Acromegaly | All study subjects with acromegaly will be studied twice - once during the active stage of their disease (pre-treatment) and a second time: 3 months after treatment of acromegaly. Controls will be studied at one time point. |
| BG001 | Healthy Controls |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Liver Fat | Change in intrahepatic fat after biochemical control of acromegaly | 20 subjects with active acromegaly completed the baseline visit. 16 subjects completed the follow-up visit after biochemical control of acromegaly. | Posted | Median | Inter-Quartile Range | Lipid/water ratio | Baseline and 3-month follow-up visit |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Acromegaly | All study subjects with acromegaly will be studied twice - once during the active stage of their disease (pre-treatment) and a second time: 3 months after treatment of acromegaly. Controls will be studied at one time point. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Miller | Massachusetts General Hospital | 617-726-3870 | KKMiller@MGH.Harvard.edu |
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| ID | Term |
|---|---|
| D000172 | Acromegaly |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
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Whole blood, serum
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Intrahepatic Lipids (Liver Fat) | Intrahepatic lipids are reported in lipid to water ratio units. | Median | Inter-Quartile Range | ratio |
|
| Intramyocellular Lipids (Muscle Fat) | Median | Inter-Quartile Range | Arbitrary Units |
|
| Visceral Fat Area | Median | Inter-Quartile Range | Cm^2 |
|
| Thigh Muscle Cross-Sectional Area | Mean | Standard Deviation | Cm^2 |
|
| Fasting Insulin | Median | Inter-Quartile Range | uU/mL |
|
| Insulin Area Under the Curve (AUC) | Median | Inter-Quartile Range | uU/mLx120 min |
|
| Insulin-like Growth Factor-1 (IGF-1) Blood Level | Median | Inter-Quartile Range | ng/ml |
|
| Participants |
|
|
| Primary | Change in Thigh Muscle Cross-sectional Area | Change in thigh muscle cross-sectional area after biochemical control of acromegaly | 20 subjects with active acromegaly completed a baseline visit. 16 subjects completed a follow-up visit after biochemical control of acromegaly had been achieved. | Posted | Mean | Standard Deviation | Cm^2 | Baseline and 3-month follow-up visit |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Healthy Controls | Healthy, matched controls | 0 | 20 | 0 | 20 | 0 | 20 |
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| D010900 |
| Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |