A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes
N/A
25 Years
55 Years
25 Years
55 Years
Open (Enrolling)
Both
Type 2 Diabetes Mellitus, Obesity
Both
Type 2 Diabetes Mellitus, Obesity
Trial Information
A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes
Inclusion Criteria:
- Age 25 to 55 years
- Mild to moderate obesity with a BMI between 30 and 40 kg/m2
- For potential subjects with BMI 35 to 40 kg/m2: T2DM confirmed by either a documented
fasting blood glucose > 126 mg/dl OR treatment with an anti-diabetic medication
- For potential subjects with BMI 30 to 35 kg/m2: T2DM that is difficult to control
medically and is recommended for the study by the subject's endocrinologist AND
treatment with an anti-diabetic medication
- Willingness to be randomized to a surgical intervention
Exclusion Criteria:
- Prior bariatric or foregut surgery
- Poor overall general health
- Impaired mental status
- Drug and/or alcohol addiction
- Current smoking
- Pregnant or plans to become pregnant
- Type 1 Diabetes Mellitus
- Portal hypertension and/or Cirrhosis
- Failed study-related nutrition or psychological assessment
- Current participation in any other research study
- Inability to provide informed consent
- Unlikely to comply with study protocol
- Unable to communicate with study staff
- Unable to exercise (walk a city block or a flight of stairs)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Feasibility of performing a randomized trial comparing two major types of bariatric surgery versus a lifestyle weight loss intervention (LWLI) induced by diet and increased physical activity in moderately obese patients with T2DM.
Outcome Time Frame:
6 months, 1 year
Safety Issue:
No
Principal Investigator
Anita P Courcoulas, MD, MPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Pittsburgh
Authority:
United States: Institutional Review Board
Study ID:
RC1DK086037
NCT ID:
NCT01047735
Start Date:
September 2009
Completion Date:
April 2015
Related Keywords:
- Type 2 Diabetes Mellitus
- Obesity
- 21+ years old
- Address
- Adult
- Amputation
- Area
- Arm
- Atheroscleroses
- Atherosclerosis
- Atherosclerotic
- Cardiovascular Disease
- Bariatrics
- Behavior Conditioning Therapy
- Behavior Modification
- Behavior Therapy
- Behavior Treatment
- Behavior or Life Style Modifications
- Behavioral
- Behavioral Conditioning Therapy
- Behavioral Modification
- Behavioral Therapy
- Behavioral Treatment
- Beta Cell
- Blindness
- Blood Pressure, High
- Blood Vessels
- Body Composition
- Body Weight decreased
- Cancers
- Cardiac infarction
- Cardiovascular Diseases
- Care, Health
- Cause of Death
- Cell Function
- Cell Process
- Cell physiology
- Cellular Function
- Cellular Physiology
- Cellular Process
- Cessation of life
- Clinical
- Clinical Trials Design
- Communities
- Conditioning Therapy
- Controlled Clinical Trials, Randomized
- Controlled Study
- Country
- D-Glucose
- Death
- Decision Making
- Dextrose
- Diabetes Mellitus
- Diabetes Mellitus, Adult-Onset
- Diabetes Mellitus, Ketosis-Resistant
- Diabetes Mellitus, Non-Insulin-Dependent
- Diabetes Mellitus, Noninsulin Dependent
- Diabetes Mellitus, Slow-Onset
- Diabetes Mellitus, Stable
- Diabetes Mellitus, Type 2
- Diabetes Mellitus, Type II
- Diet
- Disease
- Disease remission
- Disorder
- Drugs
- Dysfunction
- Effectiveness
- Epidemic
- Functional disorder
- Future
- Gastric Bypass
- Glucose
- Health
- Healthcare
- Hepatic Disorder
- Human, Adult
- Hypertension
- INFLM
- Incidence
- Inflammation
- Insulin Cell
- Insulin Resistance
- Insulin Secreting Cell
- Intestinal
- Intestines
- Intravenous Glucose Tolerance
- Intravenous Glucose Tolerance Test
- Kidney Failure
- Kidney Insufficiency
- Learning
- Life Style
- Life Style Modification
- Lifestyle
- Link
- Liver diseases
- Longitudinal Studies
- MODY
- Malignant Neoplasms
- Malignant Tumor
- Maturity-Onset Diabetes Mellitus
- Measures
- Medical
- Medication
- Metabolic
- Methods
- Modification
- Morbid Obesity
- Morbidity
- Morbidity - disease rate
- Mortality
- Mortality Vital Statistics
- Myocardial Infarct
- Myocardial Infarction
- NAFLD
- NASH
- NIDDM
- Non-Insulin Dependent Diabetes
- Non-Insulin-Dependent Diabetes Mellitus
- Non-alcoholic steatohepatitis
- Obesity
- Obesity, Morbid
- Operation
- Operative Procedures
- Operative Surgical Procedures
- Outcome
- Outcome Measure
- PROV
- Participant
- Patients
- Pharmaceutic Preparations
- Pharmaceutical Preparations
- Physical activity
- Physiopathology
- Pilot Projects
- Population
- Procedures
- Programs (PT)
- Programs [Publication Type]
- Provider
- Psychosocial Factor
- Public Health
- RMSN
- Randomized
- Randomized Controlled Clinical Trials
- Randomized Controlled Trials
- Remission
- Renal Failure
- Renal Insufficiency
- Reporting
- Resolution
- Science
- Severe obesity
- Structure
- Subcellular Process
- Surgical
- Surgical Interventions
- Surgical Procedure
- T2D
- T2DM
- Testing
- Type 2 diabetes
- Type II diabetes
- United States
- Upper arm
- Vascular Hypertensive Disease
- Vascular Hypertensive Disorder
- Weight
- Weight Loss
- Weight Reduction
- Work
- adiposity
- adult human (21+)
- adult onset diabetes
- atheromatosis
- atherosclerotic vascular disease
- bariatric surgery
- behavior intervention
- behavioral intervention
- blood glucose regulation
- body weight loss
- bowel
- cardiac infarct
- cardiovascular disorder
- cardiovascular risk
- cardiovascular risk factor
- clinical practice
- comparative effectiveness
- coronary attack
- coronary infarct
- coronary infarction
- corpulence
- corpulency
- corpulentia
- design
- designing
- diabetes
- diabetic patient
- disease/disorder
- drug/agent
- effective therapy
- effectiveness research
- fitness
- gastric banding
- gastric bypass surgery
- glucose control
- glucose homeostasis
- glucose metabolism
- glucose regulation
- heart attack
- heart infarct
- heart infarction
- hepatopathy
- hyperpiesia
- hyperpiesis
- hypertensive disease
- implantable gastric stimulation banding
- insulin resistant
- interest
- intravenous glucose tolerance test
- ketosis resistant diabetes
- life style intervention
- lifestyle intervention
- liver disorder
- long-term study
- malignancy
- maturity onset diabetes
- moderate obesity
- neoplasm/cancer
- non-alcohol fatty liver
- non-alcohol induced steatohepatitis
- non-alcoholic fatty liver
- non-alcoholic steato-hepatitis
- nonalcohol fatty liver
- nonalcoholic fatty liver
- nonalcoholic steato-hepatitis
- nonalcoholic steatohepatitis
- obese
- obese people
- obese person
- obese population
- obesity surgery
- obesity, extreme
- pathophysiology
- pilot study
- programs
- psychosocial
- psychosocial variables
- public health medicine (field)
- public health relevance
- randomisation
- randomization
- randomized controlled study
- randomized trial
- randomly assigned
- respiratory
- response
- stomach bypass
- stomach stapling
- surgery
- trial comparing
- vascular
- weight loss intervention
- weight loss surgery
- wt-loss
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Obesity
Name | Location |
|---|---|
| Magee-Womens Hospital of UPMC | Pittsburgh, Pennsylvania 15213 |
