Type 2 Diabetes MellitusmiRNANCT02459106
Effect of AT-derived miRNA on the Biology and Insulin Sensitivity of Skeletal Muscle in Humans
An observational study of Type 2 Diabetes Mellitus, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial summary
The purpose of this study is examine the effect of fat tissue-released miRNA on skeletal muscle and if abnormal fat tissue-released miRNA contributes to insulin resistance in obese individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2015to 19 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy obese insulin-resistant individuals Healthy lean insulin-sensitive individuals
Who may be able to join
- Able to communicate meaningfully with the investigator and legally competent to provide informed written consent
- 18-65 years of age
- BMI of 20-25 kg/m2 (lean subjects); 30-35 kg/m2 (obese subjects)
- Stable body weight (< 3 kg change in the last 8 weeks)
- homeostatic model assessment (HOMA)-insulin resistance <2.7 if lean; homeostatic model assessment (HOMA)-insulin resistance ≥2.7 if obese
Who cannot join
- Lactation or pregnancy, current and/or within last 6 months, per participant's report
- Female subjects postmenopausal
- Cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months)
- Liver disease (AST or ALT(alanine aminotransferase)>2.5 times the upper limit of normal)
- Kidney disease (creatinine >1.6 mg/dl)
- Anemia (hemoglobin <12 g/dl in men, <11 g/dl in women)
Show all 15Show fewer
- Thyroid dysfunction (abnormal TSH)
- HbA1c ≥6.5%
- Uncontrolled hypertension (systolic BP>160 mmHg, diastolic BP>100 mmHg)
- History of coagulopathies
- History (within the last 5 years) or presence of malignancy, (skin cancers, with the exception of melanoma, may be acceptable)
- Current or history of drug abuse or alcohol abuse (>2 drinks/day)
- Prior treatment (within last 3 months) with systemic glucocorticoids (>2 weeks), beta-blockers, drugs for weight loss, niacin or fibrates
- History of HIV, active Hepatitis B or C, or Tuberculosis (participant reported)
- Smoke > 5 cigarettes per day
Trial locations and contacts
1 site in 1 country.
United States1 site
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, 32804
About this study
The purpose of this study is examine the effect of fat tissue-released miRNA on skeletal muscle and if abnormal fat tissue-released miRNA contributes to insulin resistance in obese individuals. This information will be important for our understanding of how the body's sugar metabolism is regulated and why people who are obese become insulin resistant and are more likely to develop type 2 diabetes.
Read the detailed description
Study Objectives:
- To establish and optimize the methodology for measuring adipose tissue miRNA release.
- To establish and optimize the methodology for measuring the effect of adipose tissue-released miRNA on skeletal muscle biology and insulin sensitivity.
- To profile adipose tissue-released miRNA in lean insulin-sensitive and obese insulin-resistant healthy individuals.
- To examine the effects of adipose tissue-released miRNA from lean insulin-sensitive individuals and obese insulin-resistant individuals on skeletal muscle biology and insulin sensitivity.
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- micro-RNA, insulin resistance
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy lean insulin-sensitive individuals | This group will be studied by measuring the adipose tissue miRNA release, adipose tissue-released miRNA will be profiled, and these effects will be examined. | |
| Obese insulin-resistant individuals | This group will be studied by measuring the effect of adipose tissue-release miRNA on skeletal muscle biology and insulin sensitivity, adipose tissue-released miRNA will be profiled, and these effects will be examined on obese insulin-resistant individuals on skeletal muscle biology and insulin sensitivity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of miRNA will be measured as well as the adipose tissue specific miRNA.
The effect of miRNA released by adipose tissue from lean insulin-sensitive and from obese insulin-resistant individuals on skeletal muscle biology and insulin signaling.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study start27 May 2015
- Primary completion24 Jan 2017
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Pratley, MD, Principal investigator, Translational Research Institute for Metabolism and Diabetes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459106
- Sponsor's protocol ID
- TRIMDFH 729828
- Acronym
- miRNA
- Status last verified
- Mar 2025
- First submitted
- 22 May 2015
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Coppack SW, Jensen MD, Miles JM. In vivo regulation of lipolysis in humans. J Lipid Res. 1994 Feb;35(2):177-93.
PubMed 8169522Trayhurn P. Endocrine and signalling role of adipose tissue: new perspectives on fat. Acta Physiol Scand. 2005 Aug;184(4):285-93. doi: 10.1111/j.1365-201X.2005.01468.x.
PubMed 16026420Flier JS. Obesity wars: molecular progress confronts an expanding epidemic. Cell. 2004 Jan 23;116(2):337-50. doi: 10.1016/s0092-8674(03)01081-x.
PubMed 14744442Xie H, Sun L, Lodish HF. Targeting microRNAs in obesity. Expert Opin Ther Targets. 2009 Oct;13(10):1227-38. doi: 10.1517/14728220903190707.
PubMed 19650761Karbiener M, Fischer C, Nowitsch S, Opriessnig P, Papak C, Ailhaud G, Dani C, Amri EZ, Scheideler M. microRNA miR-27b impairs human adipocyte differentiation and targets PPARgamma. Biochem Biophys Res Commun. 2009 Dec 11;390(2):247-51. doi: 10.1016/j.bbrc.2009.09.098. Epub 2009 Oct 2.
PubMed 19800867Kim SY, Kim AY, Lee HW, Son YH, Lee GY, Lee JW, Lee YS, Kim JB. miR-27a is a negative regulator of adipocyte differentiation via suppressing PPARgamma expression. Biochem Biophys Res Commun. 2010 Feb 12;392(3):323-8. doi: 10.1016/j.bbrc.2010.01.012. Epub 2010 Jan 7.
PubMed 20060380Ortega FJ, Moreno-Navarrete JM, Pardo G, Sabater M, Hummel M, Ferrer A, Rodriguez-Hermosa JI, Ruiz B, Ricart W, Peral B, Fernandez-Real JM. MiRNA expression profile of human subcutaneous adipose and during adipocyte differentiation. PLoS One. 2010 Feb 2;5(2):e9022. doi: 10.1371/journal.pone.0009022.
PubMed 20126310Sun L, Xie H, Mori MA, Alexander R, Yuan B, Hattangadi SM, Liu Q, Kahn CR, Lodish HF. Mir193b-365 is essential for brown fat differentiation. Nat Cell Biol. 2011 Jul 10;13(8):958-65. doi: 10.1038/ncb2286.
PubMed 21743466Zaragosi LE, Wdziekonski B, Brigand KL, Villageois P, Mari B, Waldmann R, Dani C, Barbry P. Small RNA sequencing reveals miR-642a-3p as a novel adipocyte-specific microRNA and miR-30 as a key regulator of human adipogenesis. Genome Biol. 2011 Jul 18;12(7):R64. doi: 10.1186/gb-2011-12-7-r64.
PubMed 21767385Meerson A, Traurig M, Ossowski V, Fleming JM, Mullins M, Baier LJ. Human adipose microRNA-221 is upregulated in obesity and affects fat metabolism downstream of leptin and TNF-alpha. Diabetologia. 2013 Sep;56(9):1971-9. doi: 10.1007/s00125-013-2950-9. Epub 2013 Jun 12.
PubMed 23756832Pasquinelli AE, Reinhart BJ, Slack F, Martindale MQ, Kuroda MI, Maller B, Hayward DC, Ball EE, Degnan B, Muller P, Spring J, Srinivasan A, Fishman M, Finnerty J, Corbo J, Levine M, Leahy P, Davidson E, Ruvkun G. Conservation of the sequence and temporal expression of let-7 heterochronic regulatory RNA. Nature. 2000 Nov 2;408(6808):86-9. doi: 10.1038/35040556.
PubMed 11081512Lagos-Quintana M, Rauhut R, Lendeckel W, Tuschl T. Identification of novel genes coding for small expressed RNAs. Science. 2001 Oct 26;294(5543):853-8. doi: 10.1126/science.1064921.
PubMed 11679670Lee RC, Ambros V. An extensive class of small RNAs in Caenorhabditis elegans. Science. 2001 Oct 26;294(5543):862-4. doi: 10.1126/science.1065329.
PubMed 11679672Lau NC, Lim LP, Weinstein EG, Bartel DP. An abundant class of tiny RNAs with probable regulatory roles in Caenorhabditis elegans. Science. 2001 Oct 26;294(5543):858-62. doi: 10.1126/science.1065062.
PubMed 11679671Filipowicz W, Bhattacharyya SN, Sonenberg N. Mechanisms of post-transcriptional regulation by microRNAs: are the answers in sight? Nat Rev Genet. 2008 Feb;9(2):102-14. doi: 10.1038/nrg2290.
PubMed 18197166
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of AT-derived miRNA on the Biology and Insulin Sensitivity of Skeletal Muscle in Humans
- ClinicalTrials.gov ID
- NCT02459106
- Acronym / sponsor ID
- miRNA / TRIMDFH 729828
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- micro-RNA, insulin resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Study start
- 27 May 2015 (actual)
- Primary completion
- 24 Jan 2017 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 1 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is examine the effect of fat tissue-released miRNA on skeletal muscle and if abnormal fat tissue-released miRNA contributes to insulin resistance in obese individuals. This information will be important for our understanding of how the body's sugar metabolism is regulated and why people who are obese become insulin resistant and are more likely to develop type 2 diabetes.
Detailed description
Study Objectives:
- To establish and optimize the methodology for measuring adipose tissue miRNA release.
- To establish and optimize the methodology for measuring the effect of adipose tissue-released miRNA on skeletal muscle biology and insulin sensitivity.
- To profile adipose tissue-released miRNA in lean insulin-sensitive and obese insulin-resistant healthy individuals.
- To examine the effects of adipose tissue-released miRNA from lean insulin-sensitive individuals and obese insulin-resistant individuals on skeletal muscle biology and insulin sensitivity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy lean insulin-sensitive individuals | – | –This group will be studied by measuring the adipose tissue miRNA release, adipose tissue-released miRNA will be profiled, and these effects will be examined. |
| Obese insulin-resistant individuals | – | –This group will be studied by measuring the effect of adipose tissue-release miRNA on skeletal muscle biology and insulin sensitivity, adipose tissue-released miRNA will be profiled, and these effects will be examined on obese insulin-resistant individuals on skeletal muscle biology and insulin sensitivity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy obese insulin-resistant individuals Healthy lean insulin-sensitive individuals
Key inclusion criteria (5 listed)
- Able to communicate meaningfully with the investigator and legally competent to provide informed written consent
- 18-65 years of age
- BMI of 20-25 kg/m2 (lean subjects); 30-35 kg/m2 (obese subjects)
- Stable body weight (< 3 kg change in the last 8 weeks)
- homeostatic model assessment (HOMA)-insulin resistance <2.7 if lean; homeostatic model assessment (HOMA)-insulin resistance ≥2.7 if obese
Key exclusion criteria (15 listed)
- Lactation or pregnancy, current and/or within last 6 months, per participant's report
- Female subjects postmenopausal
- Cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months)
- Liver disease (AST or ALT(alanine aminotransferase)>2.5 times the upper limit of normal)
- Kidney disease (creatinine >1.6 mg/dl)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Levels of miRNA will be measured as well as the adipose tissue specific miRNA.
Time frame: 4 weeks
The effect of miRNA released by adipose tissue from lean insulin-sensitive and from obese insulin-resistant individuals on skeletal muscle biology and insulin signaling.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Background: PubMed 8169522Coppack SW, Jensen MD, Miles JM. In vivo regulation of lipolysis in humans. J Lipid Res. 1994 Feb;35(2):177-93.
- Background: PubMed 16026420Trayhurn P. Endocrine and signalling role of adipose tissue: new perspectives on fat. Acta Physiol Scand. 2005 Aug;184(4):285-93. doi: 10.1111/j.1365-201X.2005.01468.x.
- Background: PubMed 14744442Flier JS. Obesity wars: molecular progress confronts an expanding epidemic. Cell. 2004 Jan 23;116(2):337-50. doi: 10.1016/s0092-8674(03)01081-x.
- Background: PubMed 19650761Xie H, Sun L, Lodish HF. Targeting microRNAs in obesity. Expert Opin Ther Targets. 2009 Oct;13(10):1227-38. doi: 10.1517/14728220903190707.
- Background: PubMed 19800867Karbiener M, Fischer C, Nowitsch S, Opriessnig P, Papak C, Ailhaud G, Dani C, Amri EZ, Scheideler M. microRNA miR-27b impairs human adipocyte differentiation and targets PPARgamma. Biochem Biophys Res Commun. 2009 Dec 11;390(2):247-51. doi: 10.1016/j.bbrc.2009.09.098. Epub 2009 Oct 2.
- Background: PubMed 20060380Kim SY, Kim AY, Lee HW, Son YH, Lee GY, Lee JW, Lee YS, Kim JB. miR-27a is a negative regulator of adipocyte differentiation via suppressing PPARgamma expression. Biochem Biophys Res Commun. 2010 Feb 12;392(3):323-8. doi: 10.1016/j.bbrc.2010.01.012. Epub 2010 Jan 7.
- Background: PubMed 20126310Ortega FJ, Moreno-Navarrete JM, Pardo G, Sabater M, Hummel M, Ferrer A, Rodriguez-Hermosa JI, Ruiz B, Ricart W, Peral B, Fernandez-Real JM. MiRNA expression profile of human subcutaneous adipose and during adipocyte differentiation. PLoS One. 2010 Feb 2;5(2):e9022. doi: 10.1371/journal.pone.0009022.
- Background: PubMed 21743466Sun L, Xie H, Mori MA, Alexander R, Yuan B, Hattangadi SM, Liu Q, Kahn CR, Lodish HF. Mir193b-365 is essential for brown fat differentiation. Nat Cell Biol. 2011 Jul 10;13(8):958-65. doi: 10.1038/ncb2286.
- Background: PubMed 21767385Zaragosi LE, Wdziekonski B, Brigand KL, Villageois P, Mari B, Waldmann R, Dani C, Barbry P. Small RNA sequencing reveals miR-642a-3p as a novel adipocyte-specific microRNA and miR-30 as a key regulator of human adipogenesis. Genome Biol. 2011 Jul 18;12(7):R64. doi: 10.1186/gb-2011-12-7-r64.
- Background: PubMed 23756832Meerson A, Traurig M, Ossowski V, Fleming JM, Mullins M, Baier LJ. Human adipose microRNA-221 is upregulated in obesity and affects fat metabolism downstream of leptin and TNF-alpha. Diabetologia. 2013 Sep;56(9):1971-9. doi: 10.1007/s00125-013-2950-9. Epub 2013 Jun 12.
- Background: PubMed 11081512Pasquinelli AE, Reinhart BJ, Slack F, Martindale MQ, Kuroda MI, Maller B, Hayward DC, Ball EE, Degnan B, Muller P, Spring J, Srinivasan A, Fishman M, Finnerty J, Corbo J, Levine M, Leahy P, Davidson E, Ruvkun G. Conservation of the sequence and temporal expression of let-7 heterochronic regulatory RNA. Nature. 2000 Nov 2;408(6808):86-9. doi: 10.1038/35040556.
- Background: PubMed 11679670Lagos-Quintana M, Rauhut R, Lendeckel W, Tuschl T. Identification of novel genes coding for small expressed RNAs. Science. 2001 Oct 26;294(5543):853-8. doi: 10.1126/science.1064921.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Pratley, MD principal investigator
Translational Research Institute for Metabolism and Diabetes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by AdventHealth Translational Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of miRNA will be measured as well as the adipose tissue specific miRNA. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02459106, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.