Type 2 Diabetes MellitusTRIABETESNCT01047735
The TRIABETES - ARMMS-T2D Study: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes
A study testing Roux-en-Y Gastric Bypass Surgery, Laparoscopic Adjustable Gastric Banding and Lifestyle Weight Loss Intervention in people with Type 2 Diabetes Mellitus and Obesity, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Obesity
- What is being tested?
- Roux-en-Y Gastric Bypass Surgery, Laparoscopic Adjustable Gastric Banding and Lifestyle Weight Loss Intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2009to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus, Obesity
- Being tested
- Roux-en-Y Gastric Bypass Surgery, Laparoscopic Adjustable Gastric Banding, Lifestyle Weight Loss Intervention
- 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
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Atherosclerosis, Cardiovascular Diseases, Behavior, Blindness, Hypertension, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y Gastric Bypass SurgeryProcedure or surgery
Participants assigned to the Roux-en-Y Gastric Bypass treatment group will undergo a surgical procedure that limit foods intake and causes nutrients malabsorption. The procedure is performed with small incisions or laparoscopically. A small stomach pouch is created, the size of an egg, and the small intestine is connected to the pouch. Some of the stomach and small intestine are consequently bypassed by this anatomic change. Those in this treatment group will begin a gradual diet post surgery and will take life long vitamin supplements.
Laparoscopic Adjustable Gastric BandingProcedure or surgery
Also called LapBand
Those assigned to the Laparoscopic Adjustable Gastric Banding study group will undergo a surgical procedure where an adjustable silicone band is placed around the upper stomach to decrease its capacity so that you will feel full sooner. It will assist in weight loss by helping you to limit intake of calories. The band will be placed by using several small incisions and telescopic instruments. A thin tube connects the band to an access port just under the skin that you may be able to feel but you will not be able to see it. This allows the band to be tightened or loosened to decrease or increase your stomach capacity as needed. The surgery will take on average 30-45 minutes.
Lifestyle Weight Loss InterventionBehavioural
Participants will receive a standard behavior weight control program in an in-person format over a period of 12 months conducted by an experienced team of weight loss counselors. During the initial 6 months of study treatment, will attend weekly in-person individual sessions with a weight loss counselor. During months 7-12, will attend in-person sessions on the 1st and 3rd week of the month and will receive a brief (less than 10 minutes in duration) telephone call on the 2nd and 4th week of the month. Each session will focus on a specific behavioral topic related to weight loss, eating behaviors, or exercise behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Roux-en-Y Gastric Bypass Surgery | Experimental | Roux-en-Y Gastric Bypass Surgery Receives: Procedure: Roux-en-Y Gastric Bypass Surgery |
| Laparoscopic Adjustable Gastric Banding | Experimental | Laparoscopic Adjustable Gastric Banding Receives: Procedure: Laparoscopic Adjustable Gastric Banding |
| Lifestyle/Behavioral Weight Loss | Experimental | Lifestyle Weight Loss Intervention Receives: Behavioral: Lifestyle Weight Loss Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months, 1 year
Secondary outcomes (1)
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.
Measured: 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study start1 Sep 2009
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Anita P. Courcoulas, University of Pittsburgh
- Investigators
- Anita P Courcoulas, MD, MPH, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047735
- Sponsor's protocol ID
- STUDY20060163
- Other IDs
- RC1DK086037, R01DK095128-01
- Acronym
- TRIABETES
- Status last verified
- Jun 2026
- First submitted
- 12 Jan 2010
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Courcoulas AP, Patti ME, Hu B, Arterburn DE, Simonson DC, Gourash WF, Jakicic JM, Vernon AH, Beck GJ, Schauer PR, Kashyap SR, Aminian A, Cummings DE, Kirwan JP. Long-Term Outcomes of Medical Management vs Bariatric Surgery in Type 2 Diabetes. JAMA. 2024 Feb 27;331(8):654-664. doi: 10.1001/jama.2024.0318.
PubMed 38411644Courcoulas AP, Patti ME, Kirwan JP. Medical Management vs Bariatric Surgery in Type 2 Diabetes-Reply. JAMA. 2024 Jul 2;332(1):76-77. doi: 10.1001/jama.2024.8852. No abstract available.
PubMed 38829663Lundholm MD, Kirschling S, Hu B, Aminian A, Arterburn DE, Courcoulas AP, Cummings DE, Gourash WF, Patti ME, Schauer PR, Simonson DC, Vernon AH, Kirwan JP, Kashyap SR. Long-term outcomes of metabolic surgery versus medical/lifestyle therapy on metabolic dysfunction-associated fatty liver disease in adults with obesity and type 2 diabetes. Diabetes Obes Metab. 2024 Dec;26(12):6055-6061. doi: 10.1111/dom.15932. Epub 2024 Sep 12. No abstract available.
PubMed 39267261Simonson DC, Gourash WF, Arterburn DE, Hu B, Kashyap SR, Cummings DE, Patti ME, Courcoulas AP, Vernon AH, Jakicic JM, Kirschling S, Aminian A, Schauer PR, Kirwan JP. Health-Related Quality of Life and Health Utility After Metabolic/Bariatric Surgery Versus Medical/Lifestyle Intervention in Individuals With Type 2 Diabetes and Obesity: The ARMMS-T2D Study. Diabetes Care. 2025 Apr 1;48(4):537-545. doi: 10.2337/dc24-2046.
PubMed 39903478Courcoulas 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.
PubMed 24899268Courcoulas 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.
PubMed 31917447Courcoulas 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.
PubMed 26132586
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01047735
- Acronym / sponsor ID
- TRIABETES / STUDY20060163
- Conditions
- Type 2 Diabetes Mellitus, Obesity
- Keywords
- 21+ years old, Address, Adult, Amputation, Area, Arm, Atheroscleroses, Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Sep 2009 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Roux-en-Y Gastric Bypass Surgery | Experimental | Procedure: Roux-en-Y Gastric Bypass SurgeryRoux-en-Y Gastric Bypass Surgery |
| Laparoscopic Adjustable Gastric Banding | Experimental | Procedure: Laparoscopic Adjustable Gastric BandingLaparoscopic Adjustable Gastric Banding |
| Lifestyle/Behavioral Weight Loss | Experimental | Behavioral: Lifestyle Weight Loss InterventionLifestyle Weight Loss Intervention |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- Prior bariatric or foregut surgery
- Poor overall general health
- Impaired mental status
- Drug and/or alcohol addiction
- Current smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux-en-Y Gastric Bypass SurgeryParticipants assigned to the Roux-en-Y Gastric Bypass treatment group will undergo a surgical procedure that limit foods intake and causes nutrients malabsorption. The procedure is performed with small incisions or laparoscopically. A small stomach pouch is created, the size of an egg, and the small intestine is connected to the pouch. Some of the stomach and small intestine are consequently bypassed by this anatomic change. Those in this treatment group will begin a gradual diet post surgery and will take life long vitamin supplements. | Procedure or surgery | Roux-en-Y Gastric Bypass Surgery |
| Laparoscopic Adjustable Gastric BandingAlso: LapBandThose assigned to the Laparoscopic Adjustable Gastric Banding study group will undergo a surgical procedure where an adjustable silicone band is placed around the upper stomach to decrease its capacity so that you will feel full sooner. It will assist in weight loss by helping you to limit intake of calories. The band will be placed by using several small incisions and telescopic instruments. A thin tube connects the band to an access port just under the skin that you may be able to feel but you will not be able to see it. This allows the band to be tightened or loosened to decrease or increase your stomach capacity as needed. The surgery will take on average 30-45 minutes. | Procedure or surgery | Laparoscopic Adjustable Gastric Banding |
| Lifestyle Weight Loss InterventionParticipants will receive a standard behavior weight control program in an in-person format over a period of 12 months conducted by an experienced team of weight loss counselors. During the initial 6 months of study treatment, will attend weekly in-person individual sessions with a weight loss counselor. During months 7-12, will attend in-person sessions on the 1st and 3rd week of the month and will receive a brief (less than 10 minutes in duration) telephone call on the 2nd and 4th week of the month. Each session will focus on a specific behavioral topic related to weight loss, eating behaviors, or exercise behaviors. | Behavioural | Lifestyle/Behavioral Weight Loss |
Primary outcome
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.
Time frame: 6 months, 1 year
1 secondary outcome
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.
Time frame: 6 months, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Results publication: PubMed 38411644Courcoulas AP, Patti ME, Hu B, Arterburn DE, Simonson DC, Gourash WF, Jakicic JM, Vernon AH, Beck GJ, Schauer PR, Kashyap SR, Aminian A, Cummings DE, Kirwan JP. Long-Term Outcomes of Medical Management vs Bariatric Surgery in Type 2 Diabetes. JAMA. 2024 Feb 27;331(8):654-664. doi: 10.1001/jama.2024.0318.
- Results publication: PubMed 38829663Courcoulas AP, Patti ME, Kirwan JP. Medical Management vs Bariatric Surgery in Type 2 Diabetes-Reply. JAMA. 2024 Jul 2;332(1):76-77. doi: 10.1001/jama.2024.8852. No abstract available.
- Results publication: PubMed 39267261Lundholm MD, Kirschling S, Hu B, Aminian A, Arterburn DE, Courcoulas AP, Cummings DE, Gourash WF, Patti ME, Schauer PR, Simonson DC, Vernon AH, Kirwan JP, Kashyap SR. Long-term outcomes of metabolic surgery versus medical/lifestyle therapy on metabolic dysfunction-associated fatty liver disease in adults with obesity and type 2 diabetes. Diabetes Obes Metab. 2024 Dec;26(12):6055-6061. doi: 10.1111/dom.15932. Epub 2024 Sep 12. No abstract available.
- Results publication: PubMed 39903478Simonson DC, Gourash WF, Arterburn DE, Hu B, Kashyap SR, Cummings DE, Patti ME, Courcoulas AP, Vernon AH, Jakicic JM, Kirschling S, Aminian A, Schauer PR, Kirwan JP. Health-Related Quality of Life and Health Utility After Metabolic/Bariatric Surgery Versus Medical/Lifestyle Intervention in Individuals With Type 2 Diabetes and Obesity: The ARMMS-T2D Study. Diabetes Care. 2025 Apr 1;48(4):537-545. doi: 10.2337/dc24-2046.
- Results publication: PubMed 24899268Courcoulas 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.
- Results publication: PubMed 31917447Courcoulas 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.
- Results publication: PubMed 26132586Courcoulas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita P Courcoulas, MD, MPH principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roux-en-Y Gastric Bypass Surgery, Laparoscopic Adjustable Gastric Banding and Lifestyle Weight Loss Intervention in people with Type 2 Diabetes Mellitus and Obesity, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: 6 months, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01047735, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.