Physical Activity and Obesity

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Prediabetic State; Obesity; Sedentary Lifestyle

Treatments: Behavioral: High Activity

Study type: Interventional

Funder types: Other

Identifiers

NCT02060240

5KL2TR000152-08 (U.S. NIH Grant/Contract)

OHSUIRB#10299

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

High Activity Group

Experimental group

Description:

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

Treatment:

Behavioral: High Activity

Standard of Care Group

No Intervention group

Description:

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