Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 diabetes mellitus, behavioral weight loss, exercise training, hemoglobin A1c
Brief summary
This is a study of the effects of weight loss and exercise training on glucose control as measured by the Hemoglobin A 1 C in individuals with recently diagnosed Type 2 Diabetes. Study outcomes are measured at 6 months. The primary outcome is the HBA1c at 6-months. Secondary outcomes include body weight, fitness, lipid profiles and HS-CRP, a measure of inflammation. The study hypothesis is that the program of weight loss and exercise will put \>50% of individuals into remission of their type 2 Diabetes as measured by a HBA1c of \< 6.5%.
Detailed description
This is a study of the effects of weight loss and exercise training on glucose control as measured by the Hemoglobin A 1 C in individuals with recently diagnosed Type 2 Diabetes. Study outcomes are measured at 6 months. The primary outcome is the HBA1c at 6-months. Secondary outcomes include body weight, fitness, lipid profiles and HS-CRP, a measure of inflammation. The study hypothesis is that the program of weight loss and exercise will put \>50% of individuals into remission of their type 2 Diabetes as measured by a HBA1c of \< 6.5%. The study replicates the clinical situation where selected patients with new type 2 diabetes, who are motivated to try an intensive lifestyle intervention, might replicate our study intervention if we are able to show a high remission rate (e.g. \> 50%) for individuals in the study.
Interventions
BEHAVIORALbehavioral weight loss and exercise
Weight loss and exercise counseling
Sponsors
University of Vermont
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* new diagnosis of type 2 diabetes since 12 months * BMI\>27 * HBA1c \> 6.5, , 8.0
Exclusion criteria
* HBA1c \>8.0 * BMI\< 27
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | 6-months | HBA1c was the primary outcome as a measure of glucose control in individuals with recently diagnosed type 2 diabetes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lipid profile | 6 months | A lipid profile will be drawn before, and after the 6 month intervention |
| HS-C Reactive Protein | 6 months | A HS-C Reactive Protein will be drawn before and after the 6 month intervention. |
| Aerobic Fitness | 6 months | Aerobic fitness will be measured as Peak Vo2 on the treadmill before and after the 6 month intervention |
Outcome results
None listed