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A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes


N/A
25 Years
55 Years
Open (Enrolling)
Both
Type 2 Diabetes Mellitus, Obesity

Thank you

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 UPMCPittsburgh, Pennsylvania  15213