Trial Outcomes & Findings for Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly (NCT NCT01819883)

NCT ID: NCT01819883

Last Updated: 2018-06-20

Results Overview

Change in intrahepatic fat after biochemical control of acromegaly

• Recruitment status: COMPLETED
• Target enrollment: 40 participants
• Primary outcome timeframe: Baseline and 3-month follow-up visit
• Results posted on: 2018-06-20

Participant Flow

Participant milestones

Measure	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 Healthy, matched controls completed a baseline visit only
Overall Study STARTED	20	20
Overall Study COMPLETED	16	20
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ectopic Lipid Deposition and Insulin Resistance in After Treatment of Acromegaly

Baseline characteristics by cohort

Measure	Active Acromegaly n=20 Participants 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 n=20 Participants	Total n=40 Participants Total of all reporting groups
Age, Continuous	47 years STANDARD_DEVIATION 16 • n=5 Participants	47 years STANDARD_DEVIATION 17 • n=7 Participants	47 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Intrahepatic Lipids (Liver Fat)	0.02 ratio n=5 Participants	0.06 ratio n=7 Participants	0.02 ratio n=5 Participants
Intramyocellular Lipids (Muscle Fat)	8.2 Arbitrary Units n=5 Participants	10.7 Arbitrary Units n=7 Participants	9.5 Arbitrary Units n=5 Participants
Visceral Fat Area	96 Cm^2 n=5 Participants	140 Cm^2 n=7 Participants	124 Cm^2 n=5 Participants
Thigh Muscle Cross-Sectional Area	162 Cm^2 STANDARD_DEVIATION 38 • n=5 Participants	158 Cm^2 STANDARD_DEVIATION 40 • n=7 Participants	160 Cm^2 STANDARD_DEVIATION 39 • n=5 Participants
Fasting Insulin	9 uU/mL n=5 Participants	6 uU/mL n=7 Participants	8 uU/mL n=5 Participants
Insulin Area Under the Curve (AUC)	6828 uU/mLx120 min n=5 Participants	3827 uU/mLx120 min n=7 Participants	4370 uU/mLx120 min n=5 Participants
Insulin-like Growth Factor-1 (IGF-1) Blood Level	787 ng/ml n=5 Participants	174 ng/ml n=7 Participants	344 ng/ml n=5 Participants

PRIMARY outcome

Timeframe: 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.

Change in intrahepatic fat after biochemical control of acromegaly

Outcome measures

Measure	Active Acromegaly n=16 Participants All study subjects with acromegaly will be studied twice - once during the active stage of their disease (pre-treatment) and a second time: approximately 3 months after treatment of acromegaly. Controls will be studied at one time point.
Change in Liver Fat	0.03 Lipid/water ratio Interval 0.01 to 0.3

PRIMARY outcome

Timeframe: 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.

Change in thigh muscle cross-sectional area after biochemical control of acromegaly

Outcome measures

Measure	Active Acromegaly n=16 Participants All study subjects with acromegaly will be studied twice - once during the active stage of their disease (pre-treatment) and a second time: approximately 3 months after treatment of acromegaly. Controls will be studied at one time point.
Change in Thigh Muscle Cross-sectional Area	154 Cm^2 Standard Deviation 45

Adverse Events

Active Acromegaly

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karen Miller

Massachusetts General Hospital

Phone: 617-726-3870

Email: KKMiller@MGH.Harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place