Clinical trial NCT01667783: Improving Diabetes Through Lifestyle and Surgery
Official title: Improving Diabetes Through Lifestyle and Surgery Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Obesity
Type 2 Diabetes
Keywords: Obesity
Diabetes
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-08-17
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Weight loss is effective in reducing many complications of obesity, with the majority of patients who undergo bariatric surgery having substantial improvements in their weight-related illnesses. The investigators propose a pilot study in 45 subjects with mild to moderate obesity to compare how losing 10% of initial body weight via one of three common weight loss strategies (medical weight loss with a low calorie diet, Roux-en-Y gastric bypass surgery, and adjustable gastric banding) affects diabetes. While the investigators do not expect this pilot study to provide definitive answers, it will provide valuable information to design a larger trial which will help guide therapy for people with mild-moderate obesity and substantial comorbidities.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in HbA1c from baseline to final data collection
timeFrame: Average time 6 months
Secondary outcomes:
measure: Change in insulin secretion
timeFrame: Average time 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jeanne M. Clark, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Varma S, Lee CJ, Brown TT, Maruthur NM, Schweitzer M, Magnuson T, Kamel I, Clark JM. Comparative Effects of Medical Versus Surgical Weight Loss on Body Composition: a Pilot Randomized Trial. Obes Surg. 2019 Aug;29(8):2503-2510. doi: 10.1007/s11695-019-03879-4.
citation: Lee CJ, Florea L, Sears CL, Maruthur N, Potter JJ, Schweitzer M, Magnuson T, Clark JM. Changes in Gut Microbiome after Bariatric Surgery Versus Medical Weight Loss in a Pilot Randomized Trial. Obes Surg. 2019 Oct;29(10):3239-3245. doi: 10.1007/s11695-019-03976-4.