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van CCT (UK)

van CCT (UK)

Do patients with type 2 diabetes need to exercise in fasting condition to improve glucose regulation?

- candidate number19220
- NTR NumberNTR4711
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-jul-2014
- Secondary IDsEXTIDI-2014-1 
- Public TitleDo patients with type 2 diabetes need to exercise in fasting condition to improve glucose regulation?
- Scientific TitleExercise training in the fasted vs. postprandial state to augment the clinical benefits of long-term in exercise intervention in type 2 diabetes patients
- hypothesisExercise training in the fasted state might be a more effective strategy to maximize glycemic control in T2DM patients, as opposed to exercise training in postprandial state.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II)
- Inclusion criteriaFifty T2DM patients (HbA1c 6.5-9.0%) will be included in a randomized trial. Subjects with following characteristics will be included: male, age 40-75 years, sedentary (<2 hours sport/week), treated by oral blood glucose lowering medication.
- Exclusion criteriaExogenous insulin therapy or clopidogrel treatment, history of coronary events/revascularization (PCI, CABG, and/or AMI), presence of chronic pulmonary, renal disease and/or orthopedic disease that interferes with exercise training, involvement in exercise training and/or caloric restriction program for at least one year.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2014
- planned closingdate1-jun-2015
- Target number of participants40
- InterventionsSubjects are randomly assigned, by envelope, to three months of exercise training in the fasted state (before breakfast) (n=20) or postprandial state (after breakfast) (n=20). At entry of intervention, and after three months of intervention, following measurements will be executed: fasting blood sample for assessment of glycemic control and lipid profile, euglycemic hyperinsulinemic test, maximal and submaximal cardiopulmonary exercise test, body composition assessment, skeletal muscle biopsy. All participants perform three individually supervised, endurance exercise sessions per week during a 3-month intervention period. During each training session, walking and cycling exercise is performed, for a total duration of 45 min, at exactly 65% of baseline VO2peak. The exercise training intensity is standardized by continuous heart rate monitoring (Polar, Oy, Finland). Subjects which are randomized to the exercise intervention in the fasted state will exercise between 07.30-10.00 AM, followed by breakfast within 60 min after exercise. Subjects which are randomized to the exercise intervention in the postprandial state will exercise between 08.30-11.00 AM, after having consumed a breakfast <60 min ago. To standardize breakfast throughout intervention, subjects need to define this breakfast for the training days ahead of intervention, and maintain this breakfast during the entire intervention. Caffeine- and/or carbohydrate-containing beverages are not allowed during this breakfast. The caloric intake and macronutrient content of this breakfast will be calculated for all subjects, and compared between groups. During the exercises session, it is only allowed to drink water. Administration of monosaccharides will only be allowed in case of hypoglycemic symptoms.
- Primary outcomeInsulin sensitivity and glycemic control.
- Secondary outcomeExercise capacity, metabolic flexibility, body composition, muscel fibre characteristics.
- TimepointsEntry of program and 3 months later.
- Trial web site
- statusplanned
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Koning Boudewijnstichting
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD31-jul-2014 - 19-aug-2014

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