Trial Outcomes & Findings for Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity (NCT NCT04195061)

NCT ID: NCT04195061

Last Updated: 2024-01-30

Results Overview

Percent change in serum myostatin levels from pre- to 3 hours post-cardiopulmonary exercise test

• Recruitment status: COMPLETED
• Target enrollment: 28 participants
• Primary outcome timeframe: Pre- to 3 hours post-exercise
• Results posted on: 2024-01-30

Participant Flow

Participant milestones

Measure	Insulin Sensitive Homeostatic model assessment for insulin resistance (HOMA-IR) \<1.9	Insulin Resistant Homeostatic model assessment for insulin resistance (HOMA-IR) \>/=1.9
Overall Study STARTED	19	9
Overall Study COMPLETED	19	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Relative Sarcopenia and Cardiometabolic Risk in Young Adults With Obesity

Baseline characteristics by cohort

Measure	Insulin Sensitive n=19 Participants Homeostatic model assessment for insulin resistance (HOMA-IR) \<1.9	Insulin Resistant n=9 Participants Homeostatic model assessment for insulin resistance (HOMA-IR) \>/=1.9	Total n=28 Participants Total of all reporting groups
Age, Continuous	55.0 years STANDARD_DEVIATION 13.2 • n=5 Participants	50.0 years STANDARD_DEVIATION 12.0 • n=7 Participants	53.4 years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	8 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	5 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 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
Region of Enrollment United States	19 participants n=5 Participants	9 participants n=7 Participants	28 participants n=5 Participants
Fasting serum myostatin	9.84 ng/mL STANDARD_DEVIATION 3.19 • n=5 Participants	9.16 ng/mL STANDARD_DEVIATION 2.34 • n=7 Participants	9.62 ng/mL STANDARD_DEVIATION 2.92 • n=5 Participants
Body mass index	30.2 kg/m^2 STANDARD_DEVIATION 4.0 • n=5 Participants	40.8 kg/m^2 STANDARD_DEVIATION 8.8 • n=7 Participants	33.6 kg/m^2 STANDARD_DEVIATION 7.7 • n=5 Participants

PRIMARY outcome

Timeframe: Pre- to 3 hours post-exercise

Population: Four participants excluded from this analysis due to metformin use (n=2), testosterone use (n=1) or incomplete laboratory data (n=1).

Percent change in serum myostatin levels from pre- to 3 hours post-cardiopulmonary exercise test

Outcome measures

Measure	Insulin Sensitive n=17 Participants Homeostatic Model Assessment for Insulin Resistance \< 1.9	Insulin Resistant n=7 Participants Homeostatic Model Assessment for Insulin Resistance \>/= 1.9
Percent Change in Serum Myostatin Levels From Pre- to 3 Hours Post-exercise	-6.9 % change in serum myostatin Standard Deviation 41.8	8.5 % change in serum myostatin Standard Deviation 27.2

SECONDARY outcome

Timeframe: Pre- to 2 hours post-exercise

Population: Four participants excluded from the analysis due to metformin use (n=2), testosterone use (n=1), or incomplete laboratory data (n=1).

Percent change in serum myostatin levels from pre- to 2 hours post-cardiopulmonary exercise test

Outcome measures

Measure	Insulin Sensitive n=17 Participants Homeostatic Model Assessment for Insulin Resistance \< 1.9	Insulin Resistant n=7 Participants Homeostatic Model Assessment for Insulin Resistance \>/= 1.9
Percent Change in Serum Myostatin Levels From Pre- to 2 Hours Post-exercise	-9.7 % change in serum myostatin Standard Deviation 39.4	21.7 % change in serum myostatin Standard Deviation 26.0

SECONDARY outcome

Timeframe: Immediately post to 2 hours post-exercise

Population: Four participants excluded from the analysis due to metformin use (n=2), testosterone use (n=1), or incomplete laboratory data (n=1)

Percent change in serum myostatin levels from immediately post to 2 hours post-cardiopulmonary exercise test

Outcome measures

Measure	Insulin Sensitive n=17 Participants Homeostatic Model Assessment for Insulin Resistance \< 1.9	Insulin Resistant n=7 Participants Homeostatic Model Assessment for Insulin Resistance \>/= 1.9
Percent Change in Serum Myostatin Levels From Immediately Post to 2 Hours Post-exercise	-20.3 % change in serum myostatin Standard Deviation 36.0	13.5 % change in serum myostatin Standard Deviation 18.9

Adverse Events

Insulin Sensitive

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Insulin Resistant

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Insulin Sensitive n=19 participants at risk Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) \<1.9	Insulin Resistant n=9 participants at risk Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) \>/= 1.9
Cardiac disorders atrial fibrillation	0.00% 0/19 • 1 week	11.1% 1/9 • Number of events 1 • 1 week

Additional Information

Melanie S. Haines, MD

Massachusetts General Hospital

Phone: 617-726-3870

Email: mshaines@mgh.harvard.edu

Results disclosure agreements

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