Overweight and Obesity, Insulin Resistance
Conditions
Brief summary
The goal of this research study is to learn more about the hormones that muscles make during exercise, and if those hormones are associated with type 2 diabetes risk in adults who are overweight or obese. Participants will undergo exercise testing on an upright bicycle, with blood samples taken for muscle hormones before and after exercise. The hypothesis is that adults with overweight/obesity and insulin resistance will have an impaired muscle hormone profile in response to exercise compared to adults with overweight/obesity who are not insulin resistant.
Interventions
PROCEDURECardiopulmonary exercise test (CPET)
CPET studies will be performed in the Cardiovascular Performance Program exercise lab at MGH. Subjects will undergo CPET on an upright cycle ergometer with continual measurement of metabolic gas exchange via a commercially available metabolic cart as well as heart rate and blood pressure. Exercise will proceed according to a maximal effort clinical protocol. Subjects will then undergo a standardized 30-min work load on the upright cycle ergometer based on the results of the maximal effort clinical protocol.
Sponsors
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Previously enrolled in protocol 2004P000013 or protocol 2012P002276, which had overweight or obesity as inclusion criteria * Ability to walk up 3 flights of stairs and 3 city blocks (to ensure ability to complete exercise testing)
Exclusion criteria
* Unstable heart or lung disease * Exercise \>150 minutes/week * Participation in college sports
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Serum Myostatin Levels From Pre- to 3 Hours Post-exercise | Pre- to 3 hours post-exercise | Percent change in serum myostatin levels from pre- to 3 hours post-cardiopulmonary exercise test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Serum Myostatin Levels From Pre- to 2 Hours Post-exercise | Pre- to 2 hours post-exercise | Percent change in serum myostatin levels from pre- to 2 hours post-cardiopulmonary exercise test |
| Percent Change in Serum Myostatin Levels From Immediately Post to 2 Hours Post-exercise | Immediately post to 2 hours post-exercise | Percent change in serum myostatin levels from immediately post to 2 hours post-cardiopulmonary exercise test |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Insulin Sensitive Homeostatic model assessment for insulin resistance (HOMA-IR) \<1.9 | 19 |
| Insulin Resistant Homeostatic model assessment for insulin resistance (HOMA-IR) \>/=1.9 | 9 |
| Total | 28 |
Baseline characteristics
| Characteristic | Insulin Sensitive | Insulin Resistant | Total |
|---|---|---|---|
| Age, Continuous | 55.0 years STANDARD_DEVIATION 13.2 | 50.0 years STANDARD_DEVIATION 12 | 53.4 years STANDARD_DEVIATION 12.8 |
| Body mass index | 30.2 kg/m^2 STANDARD_DEVIATION 4 | 40.8 kg/m^2 STANDARD_DEVIATION 8.8 | 33.6 kg/m^2 STANDARD_DEVIATION 7.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 8 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fasting serum myostatin | 9.84 ng/mL STANDARD_DEVIATION 3.19 | 9.16 ng/mL STANDARD_DEVIATION 2.34 | 9.62 ng/mL STANDARD_DEVIATION 2.92 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 5 Participants | 21 Participants |
| Region of Enrollment United States | 19 participants | 9 participants | 28 participants |
| Sex: Female, Male Female | 8 Participants | 4 Participants | 12 Participants |
| Sex: Female, Male Male | 11 Participants | 5 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 9 |
| other Total, other adverse events | 0 / 19 | 1 / 9 |
| serious Total, serious adverse events | 0 / 19 | 0 / 9 |
Outcome results
Primary
Percent Change in Serum Myostatin Levels From Pre- to 3 Hours Post-exercise
Percent change in serum myostatin levels from pre- to 3 hours post-cardiopulmonary exercise test
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Sensitive | Percent Change in Serum Myostatin Levels From Pre- to 3 Hours Post-exercise | -6.9 % change in serum myostatin | Standard Deviation 41.8 |
| Insulin Resistant | Percent Change in Serum Myostatin Levels From Pre- to 3 Hours Post-exercise | 8.5 % change in serum myostatin | Standard Deviation 27.2 |
p-value: 0.303t-test, 2 sided
Secondary
Percent Change in Serum Myostatin Levels From Immediately Post to 2 Hours Post-exercise
Percent change in serum myostatin levels from immediately post to 2 hours post-cardiopulmonary exercise test
Time frame: 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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Sensitive | Percent Change in Serum Myostatin Levels From Immediately Post to 2 Hours Post-exercise | -20.3 % change in serum myostatin | Standard Deviation 36 |
| Insulin Resistant | Percent Change in Serum Myostatin Levels From Immediately Post to 2 Hours Post-exercise | 13.5 % change in serum myostatin | Standard Deviation 18.9 |
p-value: 0.007t-test, 2 sided
Secondary
Percent Change in Serum Myostatin Levels From Pre- to 2 Hours Post-exercise
Percent change in serum myostatin levels from pre- to 2 hours post-cardiopulmonary exercise test
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Insulin Sensitive | Percent Change in Serum Myostatin Levels From Pre- to 2 Hours Post-exercise | -9.7 % change in serum myostatin | Standard Deviation 39.4 |
| Insulin Resistant | Percent Change in Serum Myostatin Levels From Pre- to 2 Hours Post-exercise | 21.7 % change in serum myostatin | Standard Deviation 26 |
p-value: 0.035t-test, 2 sided