Clinical trial NCT02060240: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Prediabetic State
Sedentary Lifestyle
Keywords: Obesity
Prediabetic State
Sedentary Lifestyle
Insulin Resistance
Endothelium
Eicosanoids
Nitric Oxide
Regional Blood Flow
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Insulin mediated skeletal muslce blood flow and capillary recruitment
timeFrame: 3 months
Secondary outcomes:
measure: Quantification of endothelial derived Vasodilators
timeFrame: 3 months
Other outcomes:
measure: Correalte changes in fitness to vasodilators, blood flow, and insulin sensitivity
timeFrame: 3 months
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Scott M Chadderdon, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.