Type 2 Diabetes
Conditions
Brief summary
Improvement in cardiovascular mortality is related to changes in pathologic autoantibodies and in the number of circulating functional replicative competent endothelial progenitor cells (EPC's) after bariatric surgery.
Detailed description
Same as above
Interventions
BEHAVIORALpre-bariatric weight loss program
standard 6 month physician directed pre-bariatric weight loss program
PROCEDUREbariatric surgery
bariatric surgery for weight loss
Sponsors
American Society for Metabolic and Bariatric Surgery
University of South Alabama
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Type 2 Diabetes, Glucose \> 200mg/dl, currently be ing treated with oral medications and HGA1c . 6.5, and BMI .35.
Exclusion criteria
* Type 1 Diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Late Outgrowth Endothelial Progenitor Colonies | 24 months | Primary outcome is the change in Late outgrowth endothelial progenitor colonies 12 months after enrollment to surgery (LRYGB) or to standard medical therapy (SMT). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Baratric Surgery surgery vs.weight loss program 6 months prior to bariatric surgery
bariatric surgery: bariatric surgery for weight loss | 14 |
| Pre-bariatric Weight Loss Program weight loss program prior to bariatric surgery
pre-bariatric weight loss program: standard 6 month physician directed pre-bariatric weight loss program | 6 |
| Total | 20 |
Baseline characteristics
| Characteristic | Baratric Surgery | Pre-bariatric Weight Loss Program | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 6 Participants | 20 Participants |
| body mass index | 46.6 kg/m2 | 44.1 kg/m2 | 45.9 kg/m2 |
| Sex: Female, Male Female | 12 Participants | 4 Participants | 16 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 6 |
| other Total, other adverse events | 0 / 14 | 0 / 6 |
| serious Total, serious adverse events | 0 / 14 | 0 / 6 |
Outcome results
Primary
Change in Late Outgrowth Endothelial Progenitor Colonies
Primary outcome is the change in Late outgrowth endothelial progenitor colonies 12 months after enrollment to surgery (LRYGB) or to standard medical therapy (SMT).
Time frame: 24 months
Population: Study population of patients undergoing bariatric surgery compared to a group of morbidly obese patients undergoing medical diet therapy pre bariatric surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bariatric Surgery | Change in Late Outgrowth Endothelial Progenitor Colonies | LOEPC Colonies baseline | 0.3 LOEPC colonies | Standard Error 0.1 |
| Bariatric Surgery | Change in Late Outgrowth Endothelial Progenitor Colonies | LOEPC colonies 24 months post bariatric surgery | 3.1 LOEPC colonies | Standard Error 0.9 |
| Pre-bariatric Weight Loss Program | Change in Late Outgrowth Endothelial Progenitor Colonies | LOEPC Colonies baseline | 0.2 LOEPC colonies | Standard Error 0.1 |
| Pre-bariatric Weight Loss Program | Change in Late Outgrowth Endothelial Progenitor Colonies | LOEPC colonies 24 months post bariatric surgery | 0.1 LOEPC colonies | Standard Error 0.1 |
Comparison: one -way ANOVA was used for the analysisp-value: <0.05ANOVA