An interventional study of Acute Resistance Exercise in Prediabetes, sponsored by Yuan Wen. Not yet recruiting at 1 site in United States. Open to participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Yuan Wen · Not applicable, Interventional, and Basic science
This study examines how muscle cells communicate with fat cells through tiny packages called extracellular vesicles (EV) during exercise. These vesicles carry important molecules that may affect how the body processes sugar and fat. The research team observed significant variability in the adipose response to exercise, and used this variability to gain further insight into the mechanism through which mature microRNA-1 (miR-1) changes in adipose tissue. The investigators selected six subjects with the highest increase in miR-1 abundance in adipose tissue after exercise and compared them with the six subjects that had the most dramatic decrease in miR-1 abundance after exercise. The research team observed that participants intrinsically vary in their ability to endocytose EV into adipose tissue. It is unclear whether this variance in receptivity is a cause or consequence of the significant difference in EV-delivery of miR-1 to adipose tissue.
This study investigates muscle-derived extracellular vesicle (EV) communication with adipose tissue and how this pathway is altered in pre-diabetes. The investigators will recruit 40 participants (20 euglycemic controls, 20 pre-diabetic) aged 30-55 years, equally distributed by sex. Pre-diabetes will be defined as impaired fasting glucose (100-125 mg/dL), impaired glucose tolerance (2-hour oral glucose tolerance test (OGTT) 140-199 mg/dL), or HbA1C 5.7-6.4%.
Following informed consent and medical screening at the Center for Clinical and Translational Sciences, participants will undergo baseline blood draw and tissue biopsies (subcutaneous adipose and vastus lateralis muscle) one hour prior to exercise. The resistance exercise protocol consists of whole-body resistance training at 80% 1RM (repetition maximum) intensity including bench press, leg press, and pull-downs. Blood samples will be collected immediately post-exercise and at 30, 60, and 90 minutes. Post-exercise biopsies will be obtained approximately 60 minutes after exercise cessation.
Laboratory analyses will include: (1) microRNA-1 (miR-1) quantification in adipose tissue by quantitative reverse transcription polymerase chain reaction (qRT-PCR) as the primary validated outcome of EV uptake; (2) fluorescently-labeled EV uptake assessment in cultured adipocytes using microscopy; (3) RNA sequencing (RNA-seq) of adipose tissue to identify transcriptomic signatures associated with EV uptake capacity; (4) primary cell culture studies using adult-derived human adipocyte stem cells (ADHASC); and (5) EV isolation and characterization using size exclusion chromatography and density gradient centrifugation.
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's planned enrollment of 40 is below the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Yuan Wen is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will perform four exercises: squat, knee extension, leg press, and lat pulldown at 80% of 1-RM (repetition maximum) determined during a previous visit.
Behavioral: Acute Resistance Exercise
Participants will perform three sets of eight repetitions, with a 90-120 second rest between sets, with a fourth set performed to failure. All resistance exercise will be performed on pneumatic resistance devices (Keiser Sports Health Equipment, Fresno, CA).
Also known as: Strength Training
miR-1 abundance in adipose tissue
Quantification of mature microRNA-1 levels in subcutaneous adipose tissue biopsies using quantitative Real Time-PCR as validated biomarker of in vivo extracellular vesicle uptake
Time frame: 60 minutes post-exercise (single measurement)
Extracellular vesicle uptake capacity in primary adipocytes
Measurement of fluorescently-labeled extracellular vesicle internalization in cultured primary adipocytes using confocal microscopy to quantify uptake rates in units of vesicles per minute per cell.
Time frame: 24-48 hours post-isolation (in vitro culture)
Serum extracellular vesicle miR-1 content
Time-course analysis of microRNA-1 abundance in isolated serum extracellular vesicles using quantitative RT-PCR to track temporal dynamics of muscle-derived vesicle release
Time frame: Baseline, 0, 30, 60, and 90 minutes post-exercise
Adipose tissue transcriptomic signatures
RNA-sequencing analysis of subcutaneous adipose tissue to identify differential gene expression patterns associated with high versus low extracellular vesicle uptake capacity, focusing on endocytotic pathways
Time frame: 60 minutes post-exercise (single measurement)
Adrenergic receptor gene expression in adipose tissue
Quantitative RT-PCR measurement of ADRβ1, ADRβ2, and ADRβ3 receptor mRNA levels in subcutaneous adipose tissue as downstream targets of miR-1 delivery
Time frame: 60 minutes post-exercise (single measurement)
Primary muscle miR-1 transcript levels
Quantification of pri-miR-1a and pri-miR-1b primary transcript abundance in vastus lateralis muscle biopsies using quantitative RT-PCR to assess exercise-induced miR-1 biogenesis
Time frame: 60 minutes post-exercise (single measurement)
Extracellular vesicle tetraspanin marker profiles using ExoView platform
Characterization of circulating extracellular vesicle subpopulations based on surface tetraspanin protein expression (CD63, CD81, CD9) using ExoView R100 platform immunofluorescence detection and high resolution imaging. Units of Measure: Percentage of total vesicles positive for each marker.
Time frame: Baseline and 90 minutes post-exercise
Circulating extracellular vesicle count using ExoView single vesicle analysis platform
Total number of circulating extracellular vesicles quantified using the ExoView R100 platform single vesicle analysis technology with tetraspanin capture antibodies (CD63, CD81, CD9). Units of Measure: Particles per milliliter
Time frame: Baseline and 90 minutes post-exercise
Extracellular vesicle size distribution using ExoView single vesicle analysis
Size characterization of individual circulating extracellular vesicles measured using ExoView R100 platform automated analysis. Units of Measure: Nanometers (diameter).
Time frame: Baseline and 90 minutes post-exercise
Plan to share: No — Individual participant data will not be shared to protect participant privacy and confidentiality. Summary results and findings will be made available through peer-reviewed publications and presentation at scientific conferences.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Yuan Wen