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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiopulmonary exercise testing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiopulmonary exercise test (CPET) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Pre- to 3 hours post-exercise |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Pre- to 2 hours post-exercise |
| Percent Change in Serum Myostatin Levels From Immediately Post to 2 Hours Post-exercise |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with overweight or obesity
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| Name | Affiliation | Role |
|---|---|---|
| Melanie S Haines, 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 | Insulin Sensitive | Homeostatic model assessment for insulin resistance (HOMA-IR) <1.9 |
| FG001 | Insulin Resistant | Homeostatic model assessment for insulin resistance (HOMA-IR) >/=1.9 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Sensitive | Homeostatic model assessment for insulin resistance (HOMA-IR) <1.9 |
| BG001 | Insulin Resistant | Homeostatic model assessment for insulin resistance (HOMA-IR) >/=1.9 |
| 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 | 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 | Four participants excluded from this analysis due to metformin use (n=2), testosterone use (n=1) or incomplete laboratory data (n=1). | Posted | Mean | Standard Deviation | % change in serum myostatin | Pre- to 3 hours post-exercise |
|
1 week
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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 | Insulin Sensitive | Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) <1.9 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melanie S. Haines, MD | Massachusetts General Hospital | 617-726-3870 | mshaines@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 14, 2021 | Feb 7, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 14, 2021 | Feb 7, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
Percent change in serum myostatin levels from immediately post to 2 hours post-cardiopulmonary exercise test |
| Immediately post to 2 hours post-exercise |
| 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 |
|
| Region of Enrollment | Number | participants |
|
| Fasting serum myostatin | Mean | Standard Deviation | ng/mL |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
|
|
|
| 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 | Four participants excluded from the analysis due to metformin use (n=2), testosterone use (n=1), or incomplete laboratory data (n=1). | Posted | Mean | Standard Deviation | % change in serum myostatin | Pre- to 2 hours post-exercise |
|
|
|
|
| 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 | Four participants excluded from the analysis due to metformin use (n=2), testosterone use (n=1), or incomplete laboratory data (n=1) | Posted | Mean | Standard Deviation | % change in serum myostatin | Immediately post to 2 hours post-exercise |
|
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Insulin Resistant | Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) >/= 1.9 | 0 | 9 | 0 | 9 | 1 | 9 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |