Diabetes Mellitus, Type 2CROSSROADSNCT01295229
Calorie Reduction Or Surgery: Seeking Remission for Obesity And Diabetes
A study testing laparoscopic Roux-en-Y gastric bypass (RYGB) procedure and Lifestyle Intervention in people with Diabetes Mellitus, Type 2 and Obesity, run by University of Washington at 2 sites in United States.
Trial summary
The escalating pandemics of obesity and type 2 diabetes mellitus (T2DM) are among the most significant contributors to morbidity and mortality worldwide. Roux-en-Y gastric bypass (RYGB) surgery causes profound weight loss and dramatically ameliorates T2DM through mechanisms beyond just weight loss, but its role in… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- laparoscopic Roux-en-Y gastric bypass (RYGB) procedure and Lifestyle 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
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2011to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- currently enrolled at Group Health
- currently enrolled in a GH insurance product that provides coverage for laparoscopic gastric bypass (e.g., Medicare, PEBB, or has GH bariatric coverage rider)
- age on January 1, 2011 will be between 25 and 65 years
- Diabetes: must meet one or more of the following criteria during the past two years (10/1/08 - 9/30/10):
- 1+ fills for a diabetes-specific medication (oral or insulin)
- Hemoglobin A1c ≥7.0% on one or more occasions
Show all 12Show fewer
- Fasting Blood glucose ≥126 mg/dL on two or more occasions [separate days]
- Random glucose ≥200 mg/dl on two or more occasions [separate days]
- One fasting blood glucose ≥126 mg/dL plus one random glucose ≥200 mg/dl [must occur on separate days]
- One or more inpatient (primary or secondary hospital discharge) code related to diabetes. See list below.
- Two or more outpatient ICD-9 codes related to diabetes (ambulatory visits (AV) only - not telephone, email, emergency department, lab, radiology, or other (IS, OE) encounter types) [Two visits must occur on separate days]
- Obesity: All patients must have a body mass index [BMI] between 30 and <40kg/m2; weight measurement must be within the past two years (10/1/08 - 9/30/10)
Who cannot join
- Pregnancy within the past one year (10/1/09 - 9/30/10)
- Excluded if the following conditions are recorded within the past two years (10/1/08 - 9/30/10):
- malignant tumor
- ascites
- peritoneal effusion
- cirrhosis
Show all 16Show fewer
- schizophrenia
- schizoaffective disorder
- bipolar disorder
- dementia
- HIV
- inflammatory bowel disease
- dialysis
- Exclude if occurred between 1/1/95 - 9/30/10:
- Any prior bariatric or major gastrointestinal operation
- Any prior liver, heart, intestinal, and/or lung transplant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Group Health Research Institute
Seattle, Washington, 98101
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: Feasibility, Efficacy, and Mechanisms of Surgical vs Medical Diabetes Treatment
The escalating pandemics of obesity and type 2 diabetes mellitus (T2DM) are among the most significant contributors to morbidity and mortality worldwide. Roux-en-Y gastric bypass (RYGB) surgery causes profound weight loss and dramatically ameliorates T2DM through mechanisms beyond just weight loss, but its role in diabetes management and the nature of its weight-independent anti-diabetes effects are not well established because of a paucity of appropriate randomized trials, the execution of which is hindered by numerous obstacles. The investigators therefore propose a feasibility study to demonstrate our capacity to identify, recruit, randomize, and track outcomes for 40 adult Group Health members identified as having T2DM and a BMI between 30-40 kg/m2.
Read the detailed description
The overall goal of the research study is to demonstrate our capacity to identify, recruit, randomize, and track outcomes for 40 adult Group Health members identified as having T2DM and a BMI between 30-40 kg/m2.
Our cohort recruitment strategy will utilize the GH administrative and clinical databases to identify patients with T2DM and a BMI of 30-40 kg/m2. Sufficient numbers (N=4,000) of these individuals will be mailed and surveyed to identify the small minority without strong preferences regarding medical vs. surgical diabetes/obesity treatment. This subset will be invited to become better informed about both strategies using a novel, standardized patient decision aid for shared decision making (SDM) related to bariatric surgery: a high-quality educational video that provides balanced and frequently updated information about the risks and benefits of surgical and non-surgical care. After viewing SDM tool, potential subjects' "willingness to randomize" will be assessed, and a subset of willing patients will actually undergo randomization to either RYGB or a state-of-the-art intensive but reproducible medical/lifestyle intervention.
Forty patients will be randomized to either RYGB or an intensive medical/lifestyle intervention. Twenty members will be randomly assigned to intensive behavioral/medical treatment, and twenty will be randomly assigned to receive gastric bypass surgery. In the non-surgical group, the investigators will study the feasibility and resources needed to deploy a state-of-the-art intensive behavioral intervention to promote weight loss, which includes dietary and exercise components. It will be coupled with diabetes pharmacotherapy treatment consistent with Group Health Clinical Practice Guidelines (http://incontext.ghc.org/clinical/clin_topics/diabetes2/dm2_poc.html).
Patients randomized to the surgical arm will undergo a standard laparoscopic proximal RYGB, as commonly practiced by GH surgeons. The operation and post-operative care will be performed at GH by Dr. Steven Bock, Dr. Jeffery Lander, and their clinical staff, including a team of nutritionists and a Registered Nurse Case Manager who coordinates the care of patients in the GH Bariatric Surgery Program. Surgical patients will also undergo a standardized 8-week pre-operative and 10-month post-operative behavioral treatment regimen with the GH Bariatric Surgery Program.
Participants will have follow-up research visits at 3, 6, 9, and 12 months after randomization, where they will have the following measurements: standardized physically exam by Dr. Foster-Schubert; weight, waist and hip circumferences; systolic and diastolic blood pressure; resting 1-minute pulse; and fasting (12-hour) blood (50 ml) collection.
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Being tested
- laparoscopic Roux-en-Y gastric bypass (RYGB) procedure, Lifestyle Intervention
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic Roux-en-Y gastric bypass (RYGB) procedureProcedure or surgery
Also called weight loss surgery, bariatric surgery
The laparoscopic Roux-en-Y gastric bypass (RYGB) procedure is the most commonly performed bariatric procedure in the United States. Patients randomized to the surgical arm will undergo a standard laparoscopic proximal RYGB, as commonly practiced by GH surgeons, using a 90-cm alimentary limb, 50-cm biliopancreatic limb, antecolic/antegastric approach, and totally stapled technique.
Lifestyle InterventionBehavioural
Also called Diet and Exercise Program
The lifestyle intervention includes behavior-modification skills counseling combined with training in diet and exercise change. The focus of the exercise intervention is a gradual increase in brisk walking or other activities of similar moderate aerobic intensity. The exercise prescription will consist of at least 45 minutes of exercise, 5 days per week for 12 months. The diet intervention will be conducted by a research dietician with training in behavior modification, with supervision by Dr. Foster-Schubert. In week 1 the dietician will meet for a 60-minute individual session with participants at the FHCRC Prevention Center. Over the next 23 weeks the dietician will conduct one 30-minute group session per week.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention | Active comparator | Not described Receives: Behavioral: Lifestyle Intervention |
| Surgery | Active comparator | Not described Receives: Procedure: laparoscopic Roux-en-Y gastric bypass (RYGB) procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Explore the feasibility of a set of novel methods to create an appropriate randomization cohort of patients with type 2 diabetes mellitus (T2DM) and a body mass index (BMI) of 30-40 kg/m2 who are willing to be randomized into either roux-en-Y gastric bypass (RYGB) surgery or an intensive medical/lifestyle intervention. This will be assessed by comparing the number of people recruited to the number randomized and subsequently enrolled in the study.
Measured: April 2011 - January 2012
Secondary outcomes (1)
Efficacy and Mechanisms
Participants will complete research visits at Baseline, 6-month and 12-month. Both intervention groups (surgery and lifestyle) will complete the same physical assessments to compare success of the intervention. Physical measures include a fasting blood draw, DEXA scan, exercise treadmill test, anthropometric measures and vitals. Additionally, a subset of participants will be assessed for changes in their immune system before and after the intervention. Measures include an adiopose tissue biopsy and an Oral Glucose Tolerance Test.
Measured: April 2011-April 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2012
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente, Fred Hutchinson Cancer Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, David Flum, University of Washington
- Investigators
- David E Cummings, MD, Principal investigator, University of WashingtonDavid R Flum, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295229
- Sponsor's protocol ID
- 194279
- Other IDs
- 1R01DK089528-01
- Acronym
- CROSSROADS
- Status last verified
- Mar 2016
- First submitted
- 2 Feb 2011
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Banerjee S, Garrison LP Jr, Flum DR, Arterburn DE. Cost and Health Care Utilization Implications of Bariatric Surgery Versus Intensive Lifestyle and Medical Intervention for Type 2 Diabetes. Obesity (Silver Spring). 2017 Sep;25(9):1499-1508. doi: 10.1002/oby.21927. Epub 2017 Jul 19.
PubMed 28722299Cummings DE, Arterburn DE, Westbrook EO, Kuzma JN, Stewart SD, Chan CP, Bock SN, Landers JT, Kratz M, Foster-Schubert KE, Flum DR. Gastric bypass surgery vs intensive lifestyle and medical intervention for type 2 diabetes: the CROSSROADS randomised controlled trial. Diabetologia. 2016 May;59(5):945-53. doi: 10.1007/s00125-016-3903-x. Epub 2016 Mar 17.
PubMed 26983924
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Efficacy, and Mechanisms of Surgical vs Medical Diabetes Treatment
- ClinicalTrials.gov ID
- NCT01295229
- Acronym / sponsor ID
- CROSSROADS / 194279
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Kaiser Permanente, Fred Hutchinson Cancer Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 14 Feb 2011 (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.
The escalating pandemics of obesity and type 2 diabetes mellitus (T2DM) are among the most significant contributors to morbidity and mortality worldwide. Roux-en-Y gastric bypass (RYGB) surgery causes profound weight loss and dramatically ameliorates T2DM through mechanisms beyond just weight loss, but its role in diabetes management and the nature of its weight-independent anti-diabetes effects are not well established because of a paucity of appropriate randomized trials, the execution of which is hindered by numerous obstacles. The investigators therefore propose a feasibility study to demonstrate our capacity to identify, recruit, randomize, and track outcomes for 40 adult Group Health members identified as having T2DM and a BMI between 30-40 kg/m2.
Detailed description
The overall goal of the research study is to demonstrate our capacity to identify, recruit, randomize, and track outcomes for 40 adult Group Health members identified as having T2DM and a BMI between 30-40 kg/m2.
Our cohort recruitment strategy will utilize the GH administrative and clinical databases to identify patients with T2DM and a BMI of 30-40 kg/m2. Sufficient numbers (N=4,000) of these individuals will be mailed and surveyed to identify the small minority without strong preferences regarding medical vs. surgical diabetes/obesity treatment. This subset will be invited to become better informed about both strategies using a novel, standardized patient decision aid for shared decision making (SDM) related to bariatric surgery: a high-quality educational video that provides balanced and frequently updated information about the risks and benefits of surgical and non-surgical care. After viewing SDM tool, potential subjects' "willingness to randomize" will be assessed, and a subset of willing patients will actually undergo randomization to either RYGB or a state-of-the-art intensive but reproducible medical/lifestyle intervention.
Forty patients will be randomized to either RYGB or an intensive medical/lifestyle intervention. Twenty members will be randomly assigned to intensive behavioral/medical treatment, and twenty will be randomly assigned to receive gastric bypass surgery. In the non-surgical group, the investigators will study the feasibility and resources needed to deploy a state-of-the-art intensive behavioral intervention to promote weight loss, which includes dietary and exercise components. It will be coupled with diabetes pharmacotherapy treatment consistent with Group Health Clinical Practice Guidelines (http://incontext.ghc.org/clinical/clin_topics/diabetes2/dm2_poc.html).
Patients randomized to the surgical arm will undergo a standard laparoscopic proximal RYGB, as commonly practiced by GH surgeons. The operation and post-operative care will be performed at GH by Dr. Steven Bock, Dr. Jeffery Lander, and their clinical staff, including a team of nutritionists and a Registered Nurse Case Manager who coordinates the care of patients in the GH Bariatric Surgery Program. Surgical patients will also undergo a standardized 8-week pre-operative and 10-month post-operative behavioral treatment regimen with the GH Bariatric Surgery Program.
Participants will have follow-up research visits at 3, 6, 9, and 12 months after randomization, where they will have the following measurements: standardized physically exam by Dr. Foster-Schubert; weight, waist and hip circumferences; systolic and diastolic blood pressure; resting 1-minute pulse; and fasting (12-hour) blood (50 ml) collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention | Active comparator | Behavioral: Lifestyle Intervention |
| Surgery | Active comparator | Procedure: laparoscopic Roux-en-Y gastric bypass (RYGB) procedure |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- currently enrolled at Group Health
- currently enrolled in a GH insurance product that provides coverage for laparoscopic gastric bypass (e.g., Medicare, PEBB, or has GH bariatric coverage rider)
- age on January 1, 2011 will be between 25 and 65 years
- Diabetes: must meet one or more of the following criteria during the past two years (10/1/08 - 9/30/10):
- Obesity: All patients must have a body mass index [BMI] between 30 and <40kg/m2; weight measurement must be within the past two years (10/1/08 - 9/30/10)
Key exclusion criteria (16 listed)
- Pregnancy within the past one year (10/1/09 - 9/30/10)
- Excluded if the following conditions are recorded within the past two years (10/1/08 - 9/30/10):
- Exclude if occurred between 1/1/95 - 9/30/10:
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 |
|---|---|---|
| laparoscopic Roux-en-Y gastric bypass (RYGB) procedureAlso: weight loss surgery, bariatric surgeryThe laparoscopic Roux-en-Y gastric bypass (RYGB) procedure is the most commonly performed bariatric procedure in the United States. Patients randomized to the surgical arm will undergo a standard laparoscopic proximal RYGB, as commonly practiced by GH surgeons, using a 90-cm alimentary limb, 50-cm biliopancreatic limb, antecolic/antegastric approach, and totally stapled technique. | Procedure or surgery | Surgery |
| Lifestyle InterventionAlso: Diet and Exercise ProgramThe lifestyle intervention includes behavior-modification skills counseling combined with training in diet and exercise change. The focus of the exercise intervention is a gradual increase in brisk walking or other activities of similar moderate aerobic intensity. The exercise prescription will consist of at least 45 minutes of exercise, 5 days per week for 12 months. The diet intervention will be conducted by a research dietician with training in behavior modification, with supervision by Dr. Foster-Schubert. In week 1 the dietician will meet for a 60-minute individual session with participants at the FHCRC Prevention Center. Over the next 23 weeks the dietician will conduct one 30-minute group session per week. | Behavioural | Lifestyle Intervention |
Primary outcome
Feasibility
Time frame: April 2011 - January 2012
Explore the feasibility of a set of novel methods to create an appropriate randomization cohort of patients with type 2 diabetes mellitus (T2DM) and a body mass index (BMI) of 30-40 kg/m2 who are willing to be randomized into either roux-en-Y gastric bypass (RYGB) surgery or an intensive medical/lifestyle intervention. This will be assessed by comparing the number of people recruited to the number randomized and subsequently enrolled in the study.
1 secondary outcome
Efficacy and Mechanisms
Time frame: April 2011-April 2013
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- Derived from this study: PubMed 28722299Banerjee S, Garrison LP Jr, Flum DR, Arterburn DE. Cost and Health Care Utilization Implications of Bariatric Surgery Versus Intensive Lifestyle and Medical Intervention for Type 2 Diabetes. Obesity (Silver Spring). 2017 Sep;25(9):1499-1508. doi: 10.1002/oby.21927. Epub 2017 Jul 19.
- Derived from this study: PubMed 26983924Cummings DE, Arterburn DE, Westbrook EO, Kuzma JN, Stewart SD, Chan CP, Bock SN, Landers JT, Kratz M, Foster-Schubert KE, Flum DR. Gastric bypass surgery vs intensive lifestyle and medical intervention for type 2 diabetes: the CROSSROADS randomised controlled trial. Diabetologia. 2016 May;59(5):945-53. doi: 10.1007/s00125-016-3903-x. Epub 2016 Mar 17.
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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.
David E Cummings, MD principal investigator
University of Washington
David R Flum, MD, MPH principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic Roux-en-Y gastric bypass (RYGB) procedure and Lifestyle Intervention in people with Diabetes Mellitus, Type 2 and Obesity, run by University of Washington at 2 sites 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 12 inclusion and 16 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: finished, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: April 2011 - January 2012). 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 NCT01295229, which also lists 2 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 31 Mar 2016.