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Does the lowering in fat mobilisation during exercise lead to greater improvements in glycemic control in type 2 diabetes?


- candidate number19213
- NTR NumberNTR4710
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-jul-2014
- Secondary IDsLIDE2104-1 
- Public TitleDoes the lowering in fat mobilisation during exercise lead to greater improvements in glycemic control in type 2 diabetes?
- Scientific TitleImpact of lipolysis inhibition during exercise on glycemic control in type 2 diabetes
- ACRONYMLIDE
- hypothesisLipolysis inhibition during endurance exercise leads to a significantly greater improvement in 24-hour glycemic control in type 2 diabetes, as opposed to endurance exercise under normal circumstances.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II)
- Inclusion criteriaTwelve male T2DM patients (fasting blood glucose level >125mg/dl, and/or HbA1c >6.5%) will be included. Subjects with following characteristics will be included: age 45-70 years, body mass index 27.5-35.0 kg/mē, sedentary (<2 hours sport/week), treated by oral blood glucose lowering medication, no exogenous insulin therapy, no history of coronary events/revascularization, absence of chronic pulmonary, renal disease, gastric complaints/disease, and/or orthopedic disease that interferes with exercise, no involvement in exercise training and/or caloric restriction program for at least one year.
- Exclusion criteriaExogenous insulin therapy, history of coronary events/revascularization, presence of chronic pulmonary, renal disease, gastric complaints/disease, and/or orthopedic disease that interferes with exercise, involvement in exercise training and/or caloric restriction program for at least one year
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2014
- planned closingdate1-feb-2015
- Target number of participants12
- InterventionsSubjects are randomly assigned, by envelope, to an acute exercise bout with acipimox administration, followed one week later by an acute exercise bout with placebo intake, followed one week later by a control situation (no exercise) and placebo intake, or to the opposite follow order (=three experimental visits/subject). At entry of study following measurements will be executed (screening): fasting blood sample for assessment of glycemic control and lipid profile, oral glucose tolerance test, maximal cardiopulmonary exercise test, and body composition assessment. Oral blood-glucose and/or lipid-lowering medication intake remains constant during the study. During the three experimental visits, food intake will be standardized and serial blood samples will be taken.
All participants perform an acute endurance exercise bout on bike, for a total duration of 60 min, at exactly 45% of baseline peak cycling power output. The exercise intensity is monitored by continuous heart rate monitoring (Polar, Oy, Finland). Ahead of exercise, and immediately after exercise, blood pressure is assessed manually.
In one experimental trial, subjects are orally administered one capsule of 250mg acipimox (Nedios, Altana Pharma bv, Hoofddorp, NL). Potential side-effects of acipimox intake are: flushing, skin rashes, gastrointestinal complaints, headaches. In the other experimental trials, subjects are administered one capsule of 250mg of placebo.
- Primary outcome24-hour glycemic control: serial measurements of blood glucose, insulin levels, and calculation of HOMA-IR index.
- Secondary outcomeBlood free fatty acid, triglyceride, and lactate levels.
- TimepointsDuring 24 hours, 23 blood samples will be collected.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES D. Hansen
- CONTACT for SCIENTIFIC QUERIES D. Hansen
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
None
- Publicationsnone
- Brief summary
- Main changes (audit trail)
- RECORD30-jul-2014 - 19-aug-2014


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