Diabetes MellitusNCT01518023
Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy
An observational study of Diabetes Mellitus and Prediabetes, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
There is evidence that gastrointestinal operations for non weight-losing purposes are beneficial for diabetes mellitus. Aiming to analyze such hypothesis, patients submitted to gastric bypass for morbid obesity, gastrectomy for gastric cancer and colectomy for colo-rectal cancer will be compared. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Prediabetes, Morbid Obesity
- What is being tested?
- Interview, questionnaire, updated biochemical tests
- How many people
- 240 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Dec 2011
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult males and females submitted to elective curative operations will be enrolled
Who may be able to join
- Follow-up period > 3 years,
- weight stable in the last year
Who cannot join
- Reoperation or take-down of original operation,
- consumptive diseases,
- protein-calorie malnutrition,
- organ failures,
- pancreatic surgery,
- cell or organ transplantation,
Show all 9Show fewer
- type 1 diabetes,
- cognitive impairment or Alzheimer disease,
- refusal to participate in the protocol
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077
São Paulo, São Paulo, 05403-900
About this study
There is evidence that gastrointestinal operations for non weight-losing purposes are beneficial for diabetes mellitus. Aiming to analyze such hypothesis, patients submitted to gastric bypass for morbid obesity, gastrectomy for gastric cancer and colectomy for colo-rectal cancer will be compared. The end point will be changes in fasting blood glucose and hemoglobin A1c concentration.
Read the detailed description
In a prospective protocol with retrospective information, patients (N=240) undergoing bariatric Roux-en-Y gastric bypass (n=80), cancer subtotal or total gastrectomy (n=80) and right colectomy or rectosigmoidectomy (n=80) with follow-up >3 years free of disease, with or without previously impaired fasting blood glucose, will be recruited. Patients will be submitted to a questionnaire involving diet, diagnosis of diabetes and glucose-lowering drugs, body weight and other clinical items. Preoperative information available in the hospital system will be completed and current findings will be updated, including body mass index and biochemical measurements. Using the outcomes of the bariatric population as benchmark, both concerning diabetics that were ameliorated and nondiabetics that progressed to new-onset diabetes,results in the other groups will be compared. The study should answer whether gastric and colorectal surgery for cancer 1) Are beneficial for established diabetes; 2) Attenuate the conversion of normal patients to diabetes, both within a follow-up period of 3- 12 years;
- Being tested
- Interview, questionnaire, updated biochemical tests
- Keywords
- diabetes mellitus, prediabetes, fasting blood glucose, HbA1c, Roux en Y gastric bypass, Cancer gastrectomy, Cancer colorectal surgery
- Medical subject headings
- Diabetes Mellitus, Prediabetic State, Obesity, Morbid, Stomach Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interview, questionnaire, updated biochemical testsOther
Patients will be interviewed and questioned about nutritional status, diet, drugs and diagnosis/clinical course of diabetes. Routine biochemical tests will be searched and if necessary updated.
| Study group | Role | What they receive |
|---|---|---|
| Cancer gastrectomy | Patients previously submitted to partial/total gastrectomy for gastric cancer Receives: Other: Interview, questionnaire, updated biochemical tests | |
| Colorectal cancer operation | Patients previously submitted to right colectomy or rectosignoidectomy for cancer Receives: Other: Interview, questionnaire, updated biochemical tests | |
| Bariatric patients | Morbidly obese participants who underwent antiobesity Roux-en-Y gastric bypass Receives: Other: Interview, questionnaire, updated biochemical tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood glucose
Glucose improvement or deterioration comparing preoperative versus late postoperative value. Classification according to the American Diabetes Association
Measured: 3-12 years change
Secondary outcomes (1)
HbA1c
Same as fasting blood glucose (preoperative versus current change). Classification according to the American Diabetes Association.
Measured: 3-12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joel Faintuch, University of Sao Paulo
- Investigators
- Joel Faintuch, MD, PhD, Study chair, Hospital das Clinicas, Sao Paulo, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518023
- Sponsor's protocol ID
- Lessdiabetes
- Status last verified
- Jan 2012
- First submitted
- 20 Jan 2012
- Last updated
- 25 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Faintuch J, Yamaguchi CM, Dias MC, Santo MA, Faintuch JJ, Cecconello I. Biochemical correlates of bariatric-responsive diabetes. Diabetes Technol Ther. 2010 Sep;12(9):707-15. doi: 10.1089/dia.2010.0018.
PubMed 20707737Kim JW, Cheong JH, Hyung WJ, Choi SH, Noh SH. Outcome after gastrectomy in gastric cancer patients with type 2 diabetes. World J Gastroenterol. 2012 Jan 7;18(1):49-54. doi: 10.3748/wjg.v18.i1.49.
PubMed 22228970Hayashi SY, Faintuch J, Yagi OK, Yamaguchi CM, Faintuch JJ, Cecconello I. Does Roux-en-Y gastrectomy for gastric cancer influence glucose homeostasis in lean patients? Surg Endosc. 2013 Aug;27(8):2829-35. doi: 10.1007/s00464-013-2829-3. Epub 2013 Feb 23.
PubMed 23436087
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy
- ClinicalTrials.gov ID
- NCT01518023
- Acronym / sponsor ID
- Lessdiabetes
- Keywords
- diabetes mellitus, prediabetes, fasting blood glucose, HbA1c, Roux en Y gastric bypass, Cancer gastrectomy, Cancer colorectal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Jan 2012 (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.
There is evidence that gastrointestinal operations for non weight-losing purposes are beneficial for diabetes mellitus. Aiming to analyze such hypothesis, patients submitted to gastric bypass for morbid obesity, gastrectomy for gastric cancer and colectomy for colo-rectal cancer will be compared. The end point will be changes in fasting blood glucose and hemoglobin A1c concentration.
Detailed description
In a prospective protocol with retrospective information, patients (N=240) undergoing bariatric Roux-en-Y gastric bypass (n=80), cancer subtotal or total gastrectomy (n=80) and right colectomy or rectosigmoidectomy (n=80) with follow-up >3 years free of disease, with or without previously impaired fasting blood glucose, will be recruited. Patients will be submitted to a questionnaire involving diet, diagnosis of diabetes and glucose-lowering drugs, body weight and other clinical items. Preoperative information available in the hospital system will be completed and current findings will be updated, including body mass index and biochemical measurements. Using the outcomes of the bariatric population as benchmark, both concerning diabetics that were ameliorated and nondiabetics that progressed to new-onset diabetes,results in the other groups will be compared. The study should answer whether gastric and colorectal surgery for cancer 1) Are beneficial for established diabetes; 2) Attenuate the conversion of normal patients to diabetes, both within a follow-up period of 3- 12 years;
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cancer gastrectomy | – | Other: Interview, questionnaire, updated biochemical testsPatients previously submitted to partial/total gastrectomy for gastric cancer |
| Colorectal cancer operation | – | Other: Interview, questionnaire, updated biochemical testsPatients previously submitted to right colectomy or rectosignoidectomy for cancer |
| Bariatric patients | – | Other: Interview, questionnaire, updated biochemical testsMorbidly obese participants who underwent antiobesity Roux-en-Y gastric bypass |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult males and females submitted to elective curative operations will be enrolled
Key inclusion criteria (2 listed)
- Follow-up period > 3 years,
- weight stable in the last year
Key exclusion criteria (9 listed)
- Reoperation or take-down of original operation,
- consumptive diseases,
- protein-calorie malnutrition,
- organ failures,
- pancreatic surgery,
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 |
|---|---|---|
| Interview, questionnaire, updated biochemical testsPatients will be interviewed and questioned about nutritional status, diet, drugs and diagnosis/clinical course of diabetes. Routine biochemical tests will be searched and if necessary updated. | Other | Bariatric patients, Cancer gastrectomy, Colorectal cancer operation |
Primary outcome
Fasting blood glucose
Time frame: 3-12 years change
Glucose improvement or deterioration comparing preoperative versus late postoperative value. Classification according to the American Diabetes Association
1 secondary outcome
HbA1c
Time frame: 3-12 years
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 25 Jan 2012.
- Background: PubMed 20707737Faintuch J, Yamaguchi CM, Dias MC, Santo MA, Faintuch JJ, Cecconello I. Biochemical correlates of bariatric-responsive diabetes. Diabetes Technol Ther. 2010 Sep;12(9):707-15. doi: 10.1089/dia.2010.0018.
- Background: PubMed 22228970Kim JW, Cheong JH, Hyung WJ, Choi SH, Noh SH. Outcome after gastrectomy in gastric cancer patients with type 2 diabetes. World J Gastroenterol. 2012 Jan 7;18(1):49-54. doi: 10.3748/wjg.v18.i1.49.
- Derived from this study: PubMed 23436087Hayashi SY, Faintuch J, Yagi OK, Yamaguchi CM, Faintuch JJ, Cecconello I. Does Roux-en-Y gastrectomy for gastric cancer influence glucose homeostasis in lean patients? Surg Endosc. 2013 Aug;27(8):2829-35. doi: 10.1007/s00464-013-2829-3. Epub 2013 Feb 23.
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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.
Joel Faintuch, MD, PhD study chair
Hospital das Clinicas, Sao Paulo, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Prediabetes, run by University of Sao Paulo at 1 site in Brazil.
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 2 inclusion and 9 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 25 Jan 2012. 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 Brazil. 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?
Fasting blood glucose (time frame: 3-12 years change). 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 NCT01518023, which also lists 3 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 25 Jan 2012.