Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Nemours Children's Clinic
This protocol will help determine whether 'exercise snacks', alone or in combination with dietary glutamine improves diabetes control in adolescents with type 1 diabetes. All subjects for group A and B will have a full physical exam including Tanner staging as well as waist circumference measurement. A HbA1c, will be obtained as well as fasting triglycerides. A continuous glucose monitor (CGM IPro®, Medtronic Minimed, or a DexCom \^4) will be worn blindly for 6 days and data downloaded. Subjects will then be randomized to 2 study groups of 12 patients each: (A) an 'exercise group', in which subjects will perform daily 'exercise snacks' within 30 min before breakfast, lunch, and/or dinner or bedtime snack, along with a placebo drink which will be given before breakfast and dinner (twice daily); (B) an 'exercise + glutamine group', in which subjects will receive a glutamine drink (0.25 g/kg per dose) before breakfast and dinner (twice daily), and perform 'exercise snacks' before each meal. Randomization to the exercise + placebo or the exercise + glutamine group or no exercise+ no glutamine supplements will be stratified according to HbA1c range (eg, 7.0-7.4%; 7.5-8.0 %; 8.4-9.0%;9.5-10%), so as to ensure the comparability of groups. The placebo and glutamine drink will be prepared at home using measured doses of glutamine or placebo powder to be mixed in a calorie-free, flavored soft drink tailored to the child's individual taste. Patients, families and investigators will be blinded as to the contents of the supplement. Exercise snacks will be designed to be feasible using 6 min worth of simple resistance activities (SRA's) designed by the exercise physiology consultants, Drs. Churilla and Hawley. They may spread them throughout the day if needed. These will consist of activities such as alternating half-squats, calf raises, brief gluteal contractions and knee raises by using stretching bands. The tension of bands may be adjusted as needed during the study. A short video has been created showing the participants how to conduct these exercises and these will be updated periodically in order to keep their interest and compliance. An accelerometer will not be used given the short nature of these bouts of exercise. These will be completed 30 min before breakfast, lunch and dinner. Patients of group A +B will keep a record of their dietary intake and physical activity for 2 days while CGM is placed (one weekday+ one weekend day) at baseline, during the first week after study initiation and at 1,and 3 months during the study. If the family has a smart phone, a free application will be installed which is "My diet diary calorie count " for better assessment of total caloric intake during this study. Otherwise, a log book would be used. Dietary records will be examined to ensure that potential improvement in glucose control is not due to alterations in dietary intake, such as inadvertently switching to a diet composed of foods with a lower glycemic index. Compliance will be monitored by weekly contact with the study subjects either via phone call or text messaging or via MyNemours. Each participant will also be given a script with the following questions based on the group assignment: * How many times have you drank your glutamine before meals during the last week? * How many times have you performed exercise snacks before meals during the last week? In addition, subjects will be asked to check their blood glucose before meals, at bedtime and twice a week around midnight. They will be also asked to record their pulse rate three times weekly at bedtime. A spread sheet will be also provided to each patient for daily documentation of exercise performance and glutamine consumption or text us the results. The number of blood glucose measured per day prior and during the study will be recorded to determine if the compliance with BG checking has increased during the study. CGM will be placed during the first week after the study initiation, then at one month visit after the enrollment, for 6 days, then all baseline studies, including CGM, HbA1c and triglycerides will be repeated at 3 months. Every patient will undergo a body composition analysis using a dual X-ray absorptiometry (DEXA) at the beginning and the end of the study to express the changes in insulin sensitivity both per kg as well as per kg of fat free mass (FFM).Total insulin dosing will be carefully recorded as units/kg/day during the study.
Age
13–19
Sex
ALL
Healthy volunteers
Not accepted
