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Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy

Long Term Diabetes Improvement After Cancer Gastrectomy and Colectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01518023
Enrollment
240
Registered
2012-01-25
Start date
2011-01-31
Completion date
2011-12-31
Last updated
2012-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Diabetes Mellitus, Gastric Cancer, Morbid Obesity, Prediabetes

Keywords

diabetes mellitus, prediabetes, fasting blood glucose, HbA1c, Roux en Y gastric bypass, Cancer gastrectomy, Cancer colorectal surgery

Brief 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. 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;

Interventions

OTHERInterview, questionnaire, updated biochemical tests

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.

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Follow-up period \> 3 years, * weight stable in the last year

Exclusion criteria

* Reoperation or take-down of original operation, * consumptive diseases, * protein-calorie malnutrition, * organ failures, * pancreatic surgery, * cell or organ transplantation, * type 1 diabetes, * cognitive impairment or Alzheimer disease, * refusal to participate in the protocol

Design outcomes

Primary

MeasureTime frameDescription
Fasting blood glucose3-12 years changeGlucose improvement or deterioration comparing preoperative versus late postoperative value. Classification according to the American Diabetes Association

Secondary

MeasureTime frameDescription
HbA1c3-12 yearsSame as fasting blood glucose (preoperative versus current change). Classification according to the American Diabetes Association.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026