Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Johns Hopkins University
With
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Age
21–64
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
BMI 30-40 kg/m2 at screening visit 1
Age 21-64 years
Insured by collaborating insurance plan (Employee Health Plan)
Type 2 Diabetes
Medically safe to undergo surgery and approved by a psychologist
Able to exercise at a moderate level
Able to give informed consent
Willing to accept randomization to each group
Able to communicate (both written and oral) in English
Willing to use reliable method of birth control during study and ≥18 months postop (if applicable)
You may not be if
Prior bariatric surgery
Prior gastric, small or large bowel, spleen, pancreas, kidney, or liver surgery, including large ventral hernia or previous large ventral hernia repair.
Weight loss of ≥ 5% of body weight in the past 6 months
Uncontrolled diabetes (HbA1c\>8.5%)
Untreated severe diabetic retinopathy
Use of thiazolidinediones or insulin currently or within the past 3 months
Uncontrolled blood pressure (\>160/100 -may be rescreened)
Estimated glomerular filtration rate (GFR)\<30
Malignancy (except squamous or basal cell of the skin) in the past 5 years
MI, stroke or cardiovascular procedure within 12 months
Known HIV positive or use of anti-HIV therapy (HAART)
Unstable angina
Significant pulmonary disease with oxygen dependency
Chronic use (including in the past 6 months) of medications likely to cause weight gain or prevent weight loss (e.g. corticosteroids, lithium)
Use of prescription weight loss medication or over-the-counter orlistat in the past 6 months
Other serious medical condition likely to hinder accurate measurement of weight, or for which weight loss is contraindicated, or which would cause weight loss
History of severe depression requiring hospitalization in the past 12 months
Severe mental illness including bipolar disorder, schizophrenia or other psychotic disorders
Current bulimia nervosa
Unable or unwilling to use meal replacement products
Consumption of \>14 alcoholic drinks/week or \> 5 drinks on more than 2 occasions in the past 12 months
Use of illicit substances in the past 12 months
Cigarette or cigar smoking in the past 2 months
Pregnant or nursing within past 6 months
Plans to become pregnant within 2 years
Plans to relocate from the area within 1 year
Another member of household is a study participant or staff in the trial
Clareo Health | Improving Diabetes Through Lifestyle and Surgery
