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Physical Activity and Obesity

Primary Purpose

Obesity, Prediabetic State, Sedentary Lifestyle

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Activity
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Obesity, Prediabetic State, Sedentary Lifestyle, Insulin Resistance, Endothelium, Eicosanoids, Nitric Oxide, Regional Blood Flow

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

High Activity Group

Standard of Care Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
February 6, 2014
Last Updated
August 2, 2019
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT02060240
Brief Title
Physical Activity and Obesity
Official Title
Physical Activity and Obesity: The Role of Nitric Oxide and Eicosanoids in Regulating Capillary Perfusion and Vascular Insulin Resistance
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Prediabetic State, Sedentary Lifestyle
Keywords
Obesity, Prediabetic State, Sedentary Lifestyle, Insulin Resistance, Endothelium, Eicosanoids, Nitric Oxide, Regional Blood Flow

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Activity Group
Arm Type
Experimental
Arm Description
Subject randomized to High Activity group will have 36, one hour training sessions over 12 weeks.
Arm Title
Standard of Care Group
Arm Type
No Intervention
Arm Description
The standard of care group will maintain their baseline level of activity for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
High Activity
Intervention Description
The high activity group will undergo a 12 week ramped exercise protocol.
Primary Outcome Measure Information:
Title
Insulin mediated skeletal muslce blood flow and capillary recruitment
Description
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 Outcome Measure Information:
Title
Quantification of endothelial derived Vasodilators
Description
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
Other Pre-specified Outcome Measures:
Title
Correalte changes in fitness to vasodilators, blood flow, and insulin sensitivity
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott M Chadderdon, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22739105
Citation
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.
Results Reference
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PubMed Identifier
11723050
Citation
Coggins 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.
Results Reference
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PubMed Identifier
16644702
Citation
Clerk 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.
Results Reference
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Physical Activity and Obesity

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