Physical Activity and Obesity

N/ACompletedNCT02060240

Oregon Health and Science University30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Obesity Prediabetic State Sedentary Lifestyle

Interventions

High ActivityBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 30 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Males and females ages 30-60 years of age 2. Overweight and Obese (28\< BMI \<45) 3. Confirmed pre-diabetic (5.7≤ HbA1c \< 6.5) 4. Type 2 DM, Diagnosis 2 years or less, on no medications or metformin only, HbA1c ≤ 6.7 Exclusion Criteria: 1. Stage 3 chronic kidney disease (glomerular filtration rate \[GFR\] \< 60) 2. Obstructive Coronary artery disease 3. Congestive heart failure (ejection fraction \< 55%) 4. Peripheral vascular disease, 5. Degenerative joint disease, musculoskeletal disease, or peripheral vascular disease that limits ability to exercise 6. Know hypersensitivity to Definity® ultrasound contrast agent 7. Intra-cardiac or pulmonary shunt 8. The use of antithrombotic agents or a severe bleeding diathesis due to risk of bleeding with intravenous and arterial line placement 9. Physical activity greater than three hours per week 10. Pregnancy

Locations (1)

Oregon Health & Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

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

Time frame: 3 months

Secondary Outcomes

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.

Time frame: 3 months

Data from ClinicalTrials.gov

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