ObesityNCT02060240
Physical Activity and Obesity
A study testing High Activity in people with Obesity and Prediabetic State, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of the study is to see if a twelve-week exercise intervention in overweight or obese subjects with pre-diabetes or early disease course type 2 diabetes can lead to improved skeletal muscle capillary blood flow by improving substances that dilate blood vessels and result in improved insulin sensitivity. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Obesity, Prediabetic State, Sedentary Lifestyle
- What is being tested?
- High Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Apr 2017
- Phase
- Interventional
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females ages 30-60 years of age
- Overweight and Obese (28< BMI <45)
- Confirmed pre-diabetic (5.7≤ HbA1c < 6.5)
- Type 2 DM, Diagnosis 2 years or less, on no medications or metformin only, HbA1c ≤ 6.7
Who cannot join
- Stage 3 chronic kidney disease (glomerular filtration rate [GFR] < 60)
- Obstructive Coronary artery disease
- Congestive heart failure (ejection fraction < 55%)
- Peripheral vascular disease,
- Degenerative joint disease, musculoskeletal disease, or peripheral vascular disease that limits ability to exercise
- Know hypersensitivity to Definity® ultrasound contrast agent
Show all 10Show fewer
- Intra-cardiac or pulmonary shunt
- The use of antithrombotic agents or a severe bleeding diathesis due to risk of bleeding with intravenous and arterial line placement
- Physical activity greater than three hours per week
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Physical Activity and Obesity: The Role of Nitric Oxide and Eicosanoids in Regulating Capillary Perfusion and Vascular Insulin Resistance
The purpose of the study is to see if a twelve-week exercise intervention in overweight or obese subjects with pre-diabetes or early disease course type 2 diabetes can lead to improved skeletal muscle capillary blood flow by improving substances that dilate blood vessels and result in improved insulin sensitivity.
- Conditions
- Obesity, Prediabetic State, Sedentary Lifestyle
- Being tested
- High Activity
- Keywords
- Obesity, Prediabetic State, Sedentary Lifestyle, Insulin Resistance, Endothelium, Eicosanoids, Nitric Oxide, Regional Blood Flow
- Medical subject headings
- Obesity, Prediabetic State, Sedentary Behavior, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High ActivityBehavioural
The high activity group will undergo a 12 week ramped exercise protocol.
| Study group | Role | What they receive |
|---|---|---|
| High Activity Group | Experimental | Subject randomized to High Activity group will have 36, one hour training sessions over 12 weeks. Receives: Behavioral: High Activity |
| Standard of Care Group | No intervention | The standard of care group will maintain their baseline level of activity for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin mediated skeletal muslce blood flow and capillary recruitment
Contrast enhanced ultrasound skeltal muscle perfusion imaging will be performed at rest and during glucose steady state infusion during an insulin clamp. The change in blood flow will be determined between the resting state and at peak steady state to determine the absolute increase in skeletal muslce blood flow (ml/min/g) as well as the absolute increase in capillary blood volume (ml/g) of tissue
Measured: 3 months
Secondary outcomes (1)
Quantification of endothelial derived Vasodilators
To quantify the changes in endothelial derived vasodilators. For this aim nitric oxide bioavailability as tested by flow mediated vasodilation will be performed and reported as absolute change (cm) and percent change (%) in brachial artery diameter from baseline to post ischemic occlusion of the forearm. Plasma samples for eicosanoids will be collected and assessed by liquid chormatography/mass spectroscopy to to assess changes in endothelial derived vasodilators.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott M. Chadderdon, Oregon Health and Science University
- Investigators
- Scott M Chadderdon, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060240
- Sponsor's protocol ID
- OHSUIRB#10299
- Other IDs
- 5KL2TR000152-08
- Status last verified
- Aug 2019
- First submitted
- 6 Feb 2014
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Chadderdon SM, Belcik JT, Smith E, Pranger L, Kievit P, Grove KL, Lindner JR. Activity restriction, impaired capillary function, and the development of insulin resistance in lean primates. Am J Physiol Endocrinol Metab. 2012 Sep 1;303(5):E607-13. doi: 10.1152/ajpendo.00231.2012. Epub 2012 Jun 26.
PubMed 22739105Coggins M, Lindner J, Rattigan S, Jahn L, Fasy E, Kaul S, Barrett E. Physiologic hyperinsulinemia enhances human skeletal muscle perfusion by capillary recruitment. Diabetes. 2001 Dec;50(12):2682-90. doi: 10.2337/diabetes.50.12.2682.
PubMed 11723050Clerk LH, Vincent MA, Jahn LA, Liu Z, Lindner JR, Barrett EJ. Obesity blunts insulin-mediated microvascular recruitment in human forearm muscle. Diabetes. 2006 May;55(5):1436-42. doi: 10.2337/db05-1373.
PubMed 16644702
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Obesity: The Role of Nitric Oxide and Eicosanoids in Regulating Capillary Perfusion and Vascular Insulin Resistance
- ClinicalTrials.gov ID
- NCT02060240
- Acronym / sponsor ID
- OHSUIRB#10299
- Conditions
- Obesity, Prediabetic State, Sedentary Lifestyle
- Keywords
- Obesity, Prediabetic State, Sedentary Lifestyle, Insulin Resistance, Endothelium, Eicosanoids, Nitric Oxide, Regional Blood Flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 12 Feb 2014 (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 the study is to see if a twelve-week exercise intervention in overweight or obese subjects with pre-diabetes or early disease course type 2 diabetes can lead to improved skeletal muscle capillary blood flow by improving substances that dilate blood vessels and result in improved insulin sensitivity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Activity Group | Experimental | Behavioral: High ActivitySubject randomized to High Activity group will have 36, one hour training sessions over 12 weeks. |
| Standard of Care Group | No intervention | –The standard of care group will maintain their baseline level of activity for 12 weeks |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and females ages 30-60 years of age
- Overweight and Obese (28< BMI <45)
- Confirmed pre-diabetic (5.7≤ HbA1c < 6.5)
- Type 2 DM, Diagnosis 2 years or less, on no medications or metformin only, HbA1c ≤ 6.7
Key exclusion criteria (10 listed)
- Stage 3 chronic kidney disease (glomerular filtration rate [GFR] < 60)
- Obstructive Coronary artery disease
- Congestive heart failure (ejection fraction < 55%)
- Peripheral vascular disease,
- Degenerative joint disease, musculoskeletal disease, or peripheral vascular disease that limits ability to exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High ActivityThe high activity group will undergo a 12 week ramped exercise protocol. | Behavioural | High Activity Group |
Primary outcome
Insulin mediated skeletal muslce blood flow and capillary recruitment
Time frame: 3 months
Contrast enhanced ultrasound skeltal muscle perfusion imaging will be performed at rest and during glucose steady state infusion during an insulin clamp. The change in blood flow will be determined between the resting state and at peak steady state to determine the absolute increase in skeletal muslce blood flow (ml/min/g) as well as the absolute increase in capillary blood volume (ml/g) of tissue
1 secondary outcome
Quantification of endothelial derived Vasodilators
Time frame: 3 months
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 6 Aug 2019.
- Background: PubMed 22739105Chadderdon SM, Belcik JT, Smith E, Pranger L, Kievit P, Grove KL, Lindner JR. Activity restriction, impaired capillary function, and the development of insulin resistance in lean primates. Am J Physiol Endocrinol Metab. 2012 Sep 1;303(5):E607-13. doi: 10.1152/ajpendo.00231.2012. Epub 2012 Jun 26.
- Background: PubMed 11723050Coggins M, Lindner J, Rattigan S, Jahn L, Fasy E, Kaul S, Barrett E. Physiologic hyperinsulinemia enhances human skeletal muscle perfusion by capillary recruitment. Diabetes. 2001 Dec;50(12):2682-90. doi: 10.2337/diabetes.50.12.2682.
- Background: PubMed 16644702Clerk LH, Vincent MA, Jahn LA, Liu Z, Lindner JR, Barrett EJ. Obesity blunts insulin-mediated microvascular recruitment in human forearm muscle. Diabetes. 2006 May;55(5):1436-42. doi: 10.2337/db05-1373.
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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.
Scott M Chadderdon, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Activity in people with Obesity and Prediabetic State, run by Oregon Health and Science University 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 4 inclusion and 10 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 6 Aug 2019. 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?
Insulin mediated skeletal muslce blood flow and capillary recruitment (time frame: 3 months). 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 NCT02060240, which also lists 3 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 6 Aug 2019.