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The impact of prolonged walking exercise on blood glucose levels in patients with type 1 diabetes: The Four Days Marches Study.


- candidate number15072
- NTR NumberNTR4061
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-jul-2013
- Secondary IDs2012/186/1 
- Public TitleThe impact of prolonged walking exercise on blood glucose levels in patients with type 1 diabetes: The Four Days Marches Study.
- Scientific TitleUltra-endurance physical activity (30-50 km marches) and blood glucose control in patients with diabetes: The Four Days Marches Study.
- ACRONYMDiabetes and walking exercise
- hypothesisWe hypothesize that exogenous insulin requirements will be substantially reduced during the days with prolonged physical activity as opposed to the control condition. Moreover, we expect that these reduced insulin requirements will not be accompanied by an increased occurrence of hyperglycemic episodes.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 1 (DM type I)
- Inclusion criteria-Voluntary participation for the Four Days Marches, July 16-19, 2013
-Type 1 diabetes
- Exclusion criteria-HbA1c >10%
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jul-2013
- planned closingdate31-jul-2013
- Target number of participants10
- InterventionsTwenty-four-hour blood glucose homeostasis will be assessed by continuous glucose monitoring in type diabetic patients participating in the world’s largest marching event: The Four Days Marches Nijmegen.

Continuous glucose monitoring will be applied on the 2 days prior to (reference period), and during 4 subsequent of prolonged walking exercise.
- Primary outcome-Twenty-four-hour blood glucose homeostasis as measured by continuous glucose monitoring (specifically: average 24-h glucose concentrations, glycemic variability, hyperglycaemia, hypoglycaemia).

-Dosing of exogenous insulin.
- Secondary outcome-Physical activity level
-Dietary intake
- TimepointsMeasurements are conducted over the 2 days prior to the marching event, and over the 4 subsequent days of the marching event.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Jan-Willem Dijk, van
- CONTACT for SCIENTIFIC QUERIES Maria Hopman
- Sponsor/Initiator University Medical Center St. Radboud
- Funding
(Source(s) of Monetary or Material Support)
Medtronic BV.
- PublicationsN/A
- Brief summaryTwenty-four-hour glycemic control will be assessed in 10 patients with type 1 diabetes. These patients will be monitored over the 2 days prior to and during the 'Four Days Marches Nijmegen' event. The 2 days prior to the Four Days Marches will provide a reference frame for patients’ 24-h glycemic control (non-exercise control period). The subsequent 4-day period will be used to assess changes in patients’ glycemic control (hyperglycemia, hypoglycemic, glycemic variability) and insulin administration in response to ultra-endurance exercise. The unique character of the Four Days Marches event will provide novel insight into patients’ glycemic response to ultra-endurance exercise.
- Main changes (audit trail)
- RECORD4-jul-2013 - 16-jul-2013


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