Diet and Exercise Intervention in Type 2 Diabetes



Status:Active, not recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:25 - 68
Updated:4/21/2016
Start Date:October 2013

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The purpose of this study is to determine the effect of lifestyle intervention on metabolism
and blood sugar control in Type 2 Diabetics.


Inclusion Criteria:

1. Age 25-64 yrs old

2. BMI 27.0-50.0 kg/m2

3. Diagnosis of type 2 diabetes based on HbA1C>6.5% or results of an oral glucose
tolerance test or current use of anti-diabetic medications

4. HbA1C ≤9.5 %.

5. Work at Washington University in St. Louis, Barnes Jewish Hospital, St. Louis
Children's Hospital, Shriners, St. Louis College of Pharmacy, Central Institute for
the Deaf, Rehabilitation Institute of St. Louis, and any institutions affiliated with
these.

Exclusion Criteria:

1. Any change in diabetes medication in previous 3 months

2. Unstable weight (>2% change during the last 2 months before entering the study)

3. History or evidence of serious pulmonary or cardiovascular disease, including acute
coronary syndrome, heart failure requiring medications, or New York Heart Association
class III heart failure (patients with marked limitation of activity and who are
comfortable only at rest) or IV heart failure (patients who should be at complete
rest, confined to bed or chair and who have discomfort with any physical activity).

4. Evidence of serious cardiac abnormalities during exercise stress testing that
increase cardiac risk of initiating an exercise program.

5. Creatinine >1.5 mg/dL

6. Microalbuminuria; spot urine albumin:creatinine ratio >50 (50 μg albumin/mg
creatinine)

7. Coagulation disorders

8. Anemia (Hemoglobin <10.0 g/dL)

9. Liver enzymes (ALT and AST) ≥3 times the upper limit of normal

10. Uncontrolled proliferative diabetic retinopathy

11. Severe peripheral neuropathy diagnosed by monofilament testing

12. Severe organ dysfunction

13. Pregnant or breastfeeding

14. Participating in regular exercise (>1 h of structured exercise/week)

15. Joint replacement within the last year

16. Smokes tobacco

17. Severe lactose intolerance

18. Take any medication that might interfere with interpretation of the metabolic studies

19. Unable or unwilling to follow the study protocol or for any reason the research team
believes the volunteer is not an appropriate candidate for this study, including
non-compliance with screening appointments or previous medical visits.
We found this trial at
1
site
St. Louis, Missouri 63108
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St. Louis, MO
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