correlation between waist circumference & insulin requirement in IDDM
Research type
Research Study
Full title
Is there a correlation between waist circumference and daily insulin requirement in children with Type 1 Diabetes?
IRAS ID
122105
Contact name
Mathew Mathai
Contact email
Sponsor organisation
University of Leeds
Research summary
The main issues are:
1. Obtaining consent for participation in the study.
This will be done by myself or my Supervisors Dr Mathai or Dr Gorman who are the consultants providing routine Diabetes care to these children. Consent will be obtained at their routine visit to the Diabetes clinic.
Patients or parents will be given the patient information leaflet which answers some of the questions they may have. They will also have the opportunity to ask questions. They will be given the opportunity to refuse to participate and that refusing will not affect their care in any way. Patients who need more time will be allowed time until next clinic visit, which will be in three months.2. Consent to measure waist circumference.
Most patients attending the clinic get a physical examination by their doctor which may include an abdominal examination. In addition to the routine examination we will measure their waist circumference. Children or parents who are not happy with this can refuse participation.3. Consent to assess pubertal status.
Pubertal status will be assessed by asking the patient to fill in a self assessment questionnaire by ticking the boxes appropriate to their stage of development. This can be filled in, in confidence and the questionnaire will only have a study number on it and not the patient identification, in order to maintain confidentiality. Although pubertal staging is not routinely performed in the clinic, it is done from time to time, especially in cases where there is a sudden increase in insulin requirement around puberty. Most patients attending the clinic are aware that insulin requirement increases during certain stages of puberty.
Children or parents who are not comfortable with this can refuse participation.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
13/YH/0183
Date of REC Opinion
13 Aug 2013
REC opinion
Further Information Favourable Opinion