Acromegaly
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Ipsen
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages 18 - 75 yr (both groups) * Study subjects with active acromegaly * Healthy controls
Exclusion criteria
* Serum creatinine or alanine aminotransferase (ALT) \> 2 times the upper limit of normal, metastatic cancer. * Controls will be receiving no medications and have no chronic diseases, including cancer, hypertension or diabetes mellitus. * Contraindications to MRI imaging (both groups) like those with certain metal implants, surgical clips or pacemakers. * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Liver Fat | Baseline and 3-month follow-up visit | Change in intrahepatic fat after biochemical control of acromegaly |
| Change in Thigh Muscle Cross-sectional Area | Baseline and 3-month follow-up visit | Change in thigh muscle cross-sectional area after biochemical control of acromegaly |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Healthy Controls | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Active Acromegaly | Healthy Controls | Total |
|---|---|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 16 | 47 years STANDARD_DEVIATION 17 | 47 years STANDARD_DEVIATION 16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 18 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Fasting Insulin | 9 uU/mL | 6 uU/mL | 8 uU/mL |
| Insulin Area Under the Curve (AUC) | 6828 uU/mLx120 min | 3827 uU/mLx120 min | 4370 uU/mLx120 min |
| Insulin-like Growth Factor-1 (IGF-1) Blood Level | 787 ng/ml | 174 ng/ml | 344 ng/ml |
| Intrahepatic Lipids (Liver Fat) | 0.02 ratio | 0.06 ratio | 0.02 ratio |
| Intramyocellular Lipids (Muscle Fat) | 8.2 Arbitrary Units | 10.7 Arbitrary Units | 9.5 Arbitrary Units |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 17 Participants | 34 Participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants | 22 Participants |
| Thigh Muscle Cross-Sectional Area | 162 Cm^2 STANDARD_DEVIATION 38 | 158 Cm^2 STANDARD_DEVIATION 40 | 160 Cm^2 STANDARD_DEVIATION 39 |
| Visceral Fat Area | 96 Cm^2 | 140 Cm^2 | 124 Cm^2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Change in Liver Fat
Change in intrahepatic fat after biochemical control of acromegaly
Time frame: Baseline and 3-month follow-up visit
Population: 20 subjects with active acromegaly completed the baseline visit. 16 subjects completed the follow-up visit after biochemical control of acromegaly.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Active Acromegaly | Change in Liver Fat | 0.03 Lipid/water ratio |
Primary
Change in Thigh Muscle Cross-sectional Area
Change in thigh muscle cross-sectional area after biochemical control of acromegaly
Time frame: Baseline and 3-month follow-up visit
Population: 20 subjects with active acromegaly completed a baseline visit. 16 subjects completed a follow-up visit after biochemical control of acromegaly had been achieved.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Acromegaly | Change in Thigh Muscle Cross-sectional Area | 154 Cm^2 | Standard Deviation 45 |