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Glycaemic control in patients with type 2 diabetes and colorectal- or breast cancer treated with curative intent


- candidate number23616
- NTR NumberNTR5652
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jan-2016
- Secondary IDsMETC 13.0765
- Public TitleGlycaemic control in patients with type 2 diabetes and colorectal- or breast cancer treated with curative intent
- Scientific TitleGlycaemic control and diabetes treatment in patients with type 2 diabetes who are treated with curative intent for colorectal- or breast cancer
- ACRONYM-
- hypothesisWe hypothesize that the quality of diabetes treatment, measured as glycaemic control, is worse in patients with T2DM and colorectal- and breast cancer treated with curative intent, compared to T2DM patients without cancer, at 1 and 2 years after cancer treatment.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Hypertension, Dyslipemia, Breast cancer, Colorectal cancer
- Inclusion criteriaPatients with type 2 diabetes treated in primary care, who are diagnosed with primary breast- or colorectal cancer, between 1999 and 2012 and who are treated with curative intent. Curative intent for breast cancer was defined as stage 1 to 3 breast cancer or ductal carcinoma in situ (DCIS) of the breast. Curative intent for colorectal cancer was defined as stage 1 to 3, who received at least surgical treatment.
- Exclusion criteriaPatients with evidence of relapse, patients with other cancers than breast or colorectal cancer, or patients with a history of other cancers prior to breast or colorectal cancer with the exception for non-melanoma skin cancer and patients who received no cancer treatment or only hormone treatment in breast cancer are excluded. Patients without at least 1 year of follow-up in the ZODIAC study prior to the diagnosis of breast or colorectal cancer are also excluded.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-feb-2016
- planned closingdate
- Target number of participants156
- Interventions-
- Primary outcomeThe proportion of patients who achieve their individual treatment goal at 0, 12 months and 24 months after cancer diagnosis and treatment compared to baseline.
- Secondary outcomeThe proportion of patients who achieve a target cholesterol/HDL ratio equal or below 4 at 0, 12 and 24 months compared to baseline.
The proportion of patients who achieve a target systolic blood pressure equal to or below of 140 mmHg at 0, 12 and 24 months compared to baseline.
- TimepointsThe follow-up time will start at 1 year before cancer diagnosis (baseline) and the primary and secondary outcomes will be analysed at 0, 12 and 24 months after cancer diagnosis.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Dennis Schrijnders
- CONTACT for SCIENTIFIC QUERIES Dennis Schrijnders
- Sponsor/Initiator Diabetes Kenniscentrum Zwolle
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications-
- Brief summaryThis pilot study is part of a prospective cohort study, using data from the Zwolle Outpatient Diabetes project Integrating Available Care (ZODIAC) cohort and data concerning cancer from the Dutch Cancer Registry (NKR). Little is known about glycaemic control in patients who have received cancer treatment with curative intent. The aim of this project is to investigate the quality of diabetes care of type 2 diabetes patients with breast of colorectal cancer compared to those without cancer.
Patients participating in this study are diagnosed with T2DM and are treated in primary care in the Netherlands. In addition, they are diagnosed with primary breast- or colorectal cancer. For this study information about HbA1c, cholesterol/HDL ratio, blood pressure, diabetic medication use and cancer treatment were collected.
- Main changes (audit trail)
- RECORD15-jan-2016 - 12-mrt-2016


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