Physical Activity and Obesity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060240
• Other study ID #: OHSUIRB#10299
• Secondary ID: 5KL2TR000152-08
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: April 2017

Study information

• Verified date: August 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity
• Prediabetic State
• Sedentary Lifestyle

Intervention

Behavioral:
• High Activity
The high activity group will undergo a 12 week ramped exercise protocol.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correalte changes in fitness to vasodilators, blood flow, and insulin sensitivity	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.	3 months
Primary	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	3 months
Secondary	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.	3 months