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| Name | Class |
|---|---|
| Arkansas Children's Hospital Research Institute | OTHER |
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The main goal of this project is to determine whether mitochondrial function in circulating cells is related to that measured in the muscle fibers of the same subjects.
Data from human and animal models strongly suggests that reduced tissue mitochondrial function can be an early marker for detection of dysfunctional metabolism. It is unclear if tissue mitochondrial dysfunction can be detected using less invasive methodology. In this project, the investigators plan to study mitochondrial bioenergetics in circulating cells and paired muscle biopsies in two metabolic disparate groups of women; healthy lean vs. overweight/obese with/without insulin resistant women of similar age. Women of similar age that are either healthy lean or overweight/obese with/without insulin resistance will be recruited to participate in one study that includes a blood draw and a muscle biopsy. Mitochondrial function in circulating blood cells and muscle tissue will be determined. The association between circulating blood cells and muscle tissue mitochondria respiration will be determined for the two groups combined, and differences between groups will also be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy lean | Healthy lean women, 25-35 years | ||
| Overweight/obese with/without IR | Overweight/obese with/without insulin resistant women, 25-35 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Mitochondrial Function in Circulating Cells and Muscle Tissue in Young Women | Skeletal muscle (m.vastus lateralis) and peripheral blood mononuclear cell (PBMC) mitochondrial respiration were determined in response to substrate inhibitor coupling protocols using high resolution respirometry. From this, mitochondrial respiration in leak and coupled states, and reserve respiratory capacity were determined in mitochondria from skeletal muscle and from PBMCs. It was determined whether mitochondrial function in circulating cells is related to that measured in the muscle tissue of the same subjects. | During the visit, approximately 0.5 days |
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Inclusion Criteria:
Exclusion Criteria:
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Twenty (20) healthy lean and 20 insulin resistant and obese women, age 25-35 years.
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| Name | Affiliation | Role |
|---|---|---|
| Elisabet Borsheim, PhD | Arkansas Children's Nutrition Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Nutrition Center | Little Rock | Arkansas | 72202 | United States | ||
| UAMS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31211617 | Result | Rose S, Carvalho E, Diaz EC, Cotter M, Bennuri SC, Azhar G, Frye RE, Adams SH, Borsheim E. A comparative study of mitochondrial respiration in circulating blood cells and skeletal muscle fibers in women. Am J Physiol Endocrinol Metab. 2019 Sep 1;317(3):E503-E512. doi: 10.1152/ajpendo.00084.2019. Epub 2019 Jun 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Lean | Healthy lean women, 25-35 years |
| FG001 | Overweight/Obese +/- IR | Overweight/obese and/or insulin resistant women, 25-35 years |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Lean | Healthy lean women, 25-35 years |
| BG001 | Overweight/Obese With/Without IR | Overweight/obese with/without insulin resistant women, 25-35 years |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Mitochondrial Function in Circulating Cells and Muscle Tissue in Young Women | Skeletal muscle (m.vastus lateralis) and peripheral blood mononuclear cell (PBMC) mitochondrial respiration were determined in response to substrate inhibitor coupling protocols using high resolution respirometry. From this, mitochondrial respiration in leak and coupled states, and reserve respiratory capacity were determined in mitochondria from skeletal muscle and from PBMCs. It was determined whether mitochondrial function in circulating cells is related to that measured in the muscle tissue of the same subjects. | Out of the 35 enrolled, 32 participants had all samples (paired blood and muscle samples). Thus, they were their own controls, and for the main question about correlation between circulating cells and muscle mitochondrial respiration, samples were all analyzed together. This enabled comparison of circulating cells/muscle mitochondria respiration along a spectrum of BMIs and insulin resistance. | Posted | Mean | Standard Error | pmol O2/min per 400K cells | During the visit, approximately 0.5 days |
|
Approximately 10 days following biopsy
Cross-sectional study with no intervention. Moderate risk study with one blood sample and one muscle biopsy.
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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 | Healthy Lean | Healthy lean women, 25-35 years | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elisabet Borsheim, PhD | University of Arkansas for Medical Sciences; Arkansas Children's Research Institute | 501-364-3053 | EBorsheim@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2019 | Aug 27, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 7, 2017 | Aug 27, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Little Rock |
| Arkansas |
| 72202 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG000 | Healthy Lean | Healthy lean women, 25-35 years |
| OG001 | Overweight/Obese +/- IR | Overweight/obese and/or insulin resistant women, 25-35 years |
|
|
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Overweight/Obese +/- IR | Overweight/obese and/or insulin resistant women, 25-35 years | 0 | 18 | 0 | 18 | 0 | 18 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |