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Completed

NCT Number: NCT02060240

Physical Activity and Obesity

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.

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Key information

Conditions

Obesity Behavior Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Prediabetic State Sedentary Behavior Sedentary Lifestyle Signs and Symptoms

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Activity

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Quantification of endothelial derived Vasodilators

    Time frame: 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 outcomes

  1. Correalte changes in fitness to vasodilators, blood flow, and insulin sensitivity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Feb 12, 2014
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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