Clinical trial NCT01047735: The TRIABETES - ARMMS-T2D Study: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes
Official title: Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes (Triabetes) - Alliance of Randomized Trials of Medicine vs. Metabolic Surgery in Type 2 Diabetes ARMMST2D)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Obesity
Keywords: 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
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
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-01-13
Enrollment: 69
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study is being performed to begin to determine the effectiveness of two dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss in patients and promote improvements in Type 2 diabetes mellitus (T2DM) in moderately obese patients.

T2DM is currently the 6th leading cause of mortality in the United States and is a major cause of kidney failure, blindness, amputations, heart attack, and other vascular and gastro-intestinal dysfunctions. Traditionally, treatments include intensive lifestyle modifications with or without glucose lowering agents. Neither treatment alone, or in combination, results in complete resolution of diabetes and its potential long-term complications. Bariatric surgery has been proven as an effective treatment to accomplish sustained and significant weight loss for those with severe obesity and has been shown to induce long-term remission of T2DM. However, despite enthusiasm for these potential treatment options, it is not clear whether diabetes is influenced by the type of surgery or by the amount of weight lost or if bariatric surgery is more effective than non-surgical weight loss induced by diet and physical activity in T2DM patients with moderate BMIs (30-40kg/m2; Class I and Class II obesity, or approximately 65-95 pounds overweight depending on your height). More well-controlled studies are needed to more completely inform health care decision making and clinical practice in this area. This research study aims to obtain preliminary information regarding the effectiveness of two major types of bariatric surgery, Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding versus an intensive lifestyle intervention to induce weight loss with diet and increased physical activity.

Detailed description: The Specific Aims of the first phase of the study are as follows:

Aim 1. To determine the feasibility of performing a randomized trial comparing two major types of bariatric surgery, Laparoscopic Roux en Y Gastric Bypass (RNY) and Laparoscopic Adjustable Gastric Banding (GB) versus a lifestyle weight loss intervention (LWLI) induced by diet and increased physical activity in moderately obese patients (Class I and II obesity) with T2DM. We hypothesize that: 1) A randomized design with both surgical and non-surgical arms will be both feasible and acceptable to participants and to providers 2) There will be no difference in retention rates between the LWLI and surgical arms (RNY, GB) of the study and it will provide estimates of overall retention for future studies.

Aim 2. To obtain preliminary information regarding the effectiveness of two dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss with diet and increased physical activity. We hypothesize that: 1) RNY will be superior to GB and LWLI in weight lost in 12 months.

Aim 3. To explore the feasibility, methods for, and implementation of a range of early outcome measures including; resolution of diabetes, glucose control, medication usage, insulin resistance, beta cell function, body composition, objective measures of physical activity, and several psychosocial measures. We hypothesize that: 1) Participants will be willing to undergo a range of early outcome testing measures to assess metabolic change, body composition alterations, objective physical activity, and psychosocial factors. 2) Measures of T2DM improvement including an intravenous glucose tolerance test (IVGTT) will be feasible in a subset of participants in each study arm and RNY will be superior to both GB and LWLI for the clinical and metabolic improvement of T2DM. 3) The LWLI group will show improvements in physical activity compared to RNY and GB.

Eligibility criteria: 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)

Primary outcomes:
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.
timeFrame: 6 months, 1 year
Secondary outcomes:
measure: Preliminary information regarding the effectiveness of two dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss with diet and increased physical activity.
timeFrame: 6 months, 1 year
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: William F Gourash
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Anita P Courcoulas, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Courcoulas AP, Goodpaster BH, Eagleton JK, Belle SH, Kalarchian MA, Lang W, Toledo FG, Jakicic JM. Surgical vs medical treatments for type 2 diabetes mellitus: a randomized clinical trial. JAMA Surg. 2014 Jul;149(7):707-15. doi: 10.1001/jamasurg.2014.467.
citation: Courcoulas AP, Gallagher JW, Neiberg RH, Eagleton EB, DeLany JP, Lang W, Punchai S, Gourash W, Jakicic JM. Bariatric Surgery vs Lifestyle Intervention for Diabetes Treatment: 5-Year Outcomes From a Randomized Trial. J Clin Endocrinol Metab. 2020 Mar 1;105(3):866-76. doi: 10.1210/clinem/dgaa006.
citation: Courcoulas AP, Belle SH, Neiberg RH, Pierson SK, Eagleton JK, Kalarchian MA, DeLany JP, Lang W, Jakicic JM. Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical Trial. JAMA Surg. 2015 Oct;150(10):931-40. doi: 10.1001/jamasurg.2015.1534.