Physical Activity and Obesity

Sponsor

Oregon Health and Science University (Other)

Overall Status

Completed

CT.gov ID

NCT02060240

Collaborator

(none)

Enrollment

Location

Arms

37.9

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Prediabetic State Sedentary Lifestyle	Behavioral: High Activity	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Physical Activity and Obesity: The Role of Nitric Oxide and Eicosanoids in Regulating Capillary Perfusion and Vascular Insulin Resistance

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High Activity Group Subject randomized to High Activity group will have 36, one hour training sessions over 12 weeks.	Behavioral: High Activity The high activity group will undergo a 12 week ramped exercise protocol.
No Intervention: Standard of Care Group The standard of care group will maintain their baseline level of activity for 12 weeks

Arm

Intervention/Treatment

Experimental: High Activity Group

Subject randomized to High Activity group will have 36, one hour training sessions over 12 weeks.

Behavioral: High Activity

The high activity group will undergo a 12 week ramped exercise protocol.

No Intervention: Standard of Care Group

The standard of care group will maintain their baseline level of activity for 12 weeks

Outcome Measures

Primary Outcome Measures

Insulin mediated skeletal muslce blood flow and capillary recruitment [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

Secondary Outcome Measures

Quantification of endothelial derived Vasodilators [3 months]
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.

Other Outcome Measures

Correalte changes in fitness to vasodilators, blood flow, and insulin sensitivity [3 months]
Aim 3. To correlate changes in fitness as measured by peak VO2 and anaerobic threshold during cardiopulmonary exercise testing with changes in endothelial derived vasodilators, skeletal muscle blood flow, and insulin sensitivity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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
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