Diabetes Mellitus, Type 1NCT03199638
Exercise Snacks and Glutamine to Improve Glucose Control in Adolescents With Type 1 Diabetes
A study testing Exercise in people with Diabetes Mellitus, Type 1 and Autoimmune Diseases, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
This project will assess the feasibility and efficacy of the use of exercise and dietary supplementation with a non essential amino acid - glutamine - a component of most protein supplements, on the regulation of plasma glucose homeostasis in a clinical setting of children with type 1 diabetes (T1D). Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Autoimmune Diseases, Diabetes Mellitus
- What is being tested?
- Exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2016to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Type 1 diabetes for >12 months
- Age between 13 and 19 years
- Males and females at Tanner stage 4 and 5
- All insulin programs, including intermediate,short acting insulin, Lantus, Detemir and short acting insulin or insulin pump therapy.
- Weight of 40 kilograms or higher.
- Hemoglobin A1C between 7%-10% and total daily insulin dose at least 0.9 unit/kg/day.
Show all 18Show fewer
- BMI between 10 centile to less than 95 percentiles.
- Patients on stable thyroid replacement therapy will be allowed to participate. Exclusion Criteria
- Celiac disease.
- Cystic Fibrosis
- Chronic steroid therapy
- Chronic medications that may interfere with glucose metabolism or liver function.
- History of mental retardation
- Presence of diabetic complications
- Being pregnant or having positive pregnancy test at any time during the study.
- Presence of significant anemia (hemoglobin less than11 g/dL)
- Presence of intercurrent infection
- Subjects involved in an active exercise program or in an organized sport team
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Clinic
Jacksonville, Florida, 32207
About this study
This project will assess the feasibility and efficacy of the use of exercise and dietary supplementation with a non essential amino acid - glutamine - a component of most protein supplements, on the regulation of plasma glucose homeostasis in a clinical setting of children with type 1 diabetes (T1D). The study specifically targets patients in puberty as this period is associated with a physiological decline in insulin sensitivity, the latter often associated with poor control. Although physical exercise has long been known to exert beneficial effects on metabolism, lack of time is the most common reason perceived as preventing the performance of exercise in both healthy and diabetic subjects. In earlier studies, the investigators showed that oral supplementation with glutamine, a non essential amino acid given prior to exercise decreases overnight post-exercise blood glucose in adolescents with T1D. Hence, the objective of the current study is to investigate if a novel way of exercising, such as performing 6 short bouts of just 1 min each of intense exercise ('exercise snacks') 30 min before meals, with or without glutamine, improves glycemic control in adolescents with T1D. Designing innovative ways to improve diabetes control in adolescents is highly desirable. The specific aim of the project is to determine whether the sustained use of the proposed exercise snacks with or without glutamine results in diminished glycemic variability and/or improved glucose control
Read the detailed description
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.
- Conditions
- Diabetes Mellitus, Type 1, Autoimmune Diseases, Diabetes Mellitus, Endocrine System Diseases, Glucose Metabolism Disorders, Immune System Diseases
- Being tested
- Glutamine vs. Placebo, Exercise
- Keywords
- Continuous Glucose Monitoring, Children, Exercise, Glycated hemoglobin, Adolescents, Insulin sensitivity, Glutamine
- Medical subject headings
- Diabetes Mellitus, Type 1, Autoimmune Diseases, Diabetes Mellitus, Endocrine System Diseases, Glucose Metabolism Disorders, Immune System Diseases, Metabolic Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glutamine vs. PlaceboDrug
oral supplementation with either glutamine or placebo twice daily for 3 months
ExerciseBehavioural
short bouts of exercise ('exercise snacks') 3 times daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| an exercise group | Experimental | 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); Receives: Behavioral: Exercise |
| an exercise + glutamine group | Experimental | 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 Receives: Drug: Glutamine vs. Placebo; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c, Glycated Hemoglobin
change in glycated hemoglobin
Measured: baseline vs. at 3 months
Secondary outcomes (6)
Change in the Mean Amplitude of Glycemic Excursions (MAGE)
MAGE describes the average amplitude of glycemic variations measured using continuous glucose monitoring (CGM)
Measured: before vs. at 3 months
Change in Percent of Blood Glucose (BG) Within Target
Percent of BG between 70 and 180 mg/dL, as measured using Continuous Glucose Monitor (CGM)
Measured: baseline vs. at 3 months
Percent of BG <70 mg/dL
Change in Percent of BG below 70 mg/dL, as determined by Continuous Glucose Monitor (CGM)
Measured: baseline vs. at 3 months
Percent Blood Glucose (BG) >180
Change in Percent of BG above 180 mg, as determined using Continuous Glucose Monitor (CGM)
Measured: baseline vs. at 3 months
Insulin Dose
Change in insulin dose (Units/kg/day) used at home
Measured: baseline vs. at 3 months
Insulin Sensitivity Score (ISS)
Change in insulin sensitivity score, determined using SEARCH ISS model published equation: logeIS = 4.64725 - 0.02032 × (waist, cm) - 0.09779 × (HbA1c, %) - 0.00235 × (Triglycerides, mg/dL). The range of ISS scores is between 1-15. Higher scores imply a better insulin sensistivity.
Measured: baseline vs. at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start1 Apr 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominique Darmaun, Nemours Children's Clinic
- Investigators
- Dominique Darmaun, PhD, MD, Principal investigator, Nemours Children's Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199638
- Sponsor's protocol ID
- Nemours IRB #790908
- Status last verified
- Jul 2023
- First submitted
- 20 Jun 2017
- Last updated
- 14 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bloch CA, Clemons P, Sperling MA. Puberty decreases insulin sensitivity. J Pediatr. 1987 Mar;110(3):481-7. doi: 10.1016/s0022-3476(87)80522-x.
PubMed 2950219Caprio S, Cline G, Boulware S, Permanente C, Shulman GI, Sherwin RS, Tamborlane WV. Effects of puberty and diabetes on metabolism of insulin-sensitive fuels. Am J Physiol. 1994 Jun;266(6 Pt 1):E885-91. doi: 10.1152/ajpendo.1994.266.6.E885.
PubMed 8023918Amiel SA, Sherwin RS, Simonson DC, Lauritano AA, Tamborlane WV. Impaired insulin action in puberty. A contributing factor to poor glycemic control in adolescents with diabetes. N Engl J Med. 1986 Jul 24;315(4):215-9. doi: 10.1056/NEJM198607243150402.
PubMed 3523245Arslanian S, Heil BV, Kalhan SC. Hepatic insulin action in adolescents with insulin-dependent diabetes mellitus: relationship with long-term glycemic control. Metabolism. 1993 Mar;42(3):283-90. doi: 10.1016/0026-0495(93)90075-y.
PubMed 8487645Richter EA, Hargreaves M. Exercise, GLUT4, and skeletal muscle glucose uptake. Physiol Rev. 2013 Jul;93(3):993-1017. doi: 10.1152/physrev.00038.2012.
PubMed 23899560Wahren J, Felig P, Hagenfeldt L. Physical exercise and fuel homeostasis in diabetes mellitus. Diabetologia. 1978 Apr;14(4):213-22. doi: 10.1007/BF01219419. No abstract available.
PubMed 640298Goodyear LJ, King PA, Hirshman MF, Thompson CM, Horton ED, Horton ES. Contractile activity increases plasma membrane glucose transporters in absence of insulin. Am J Physiol. 1990 Apr;258(4 Pt 1):E667-72. doi: 10.1152/ajpendo.1990.258.4.E667.
PubMed 2159218Wasserman DH, Geer RJ, Rice DE, Bracy D, Flakoll PJ, Brown LL, Hill JO, Abumrad NN. Interaction of exercise and insulin action in humans. Am J Physiol. 1991 Jan;260(1 Pt 1):E37-45. doi: 10.1152/ajpendo.1991.260.1.E37.
PubMed 1987792Baar K, Wende AR, Jones TE, Marison M, Nolte LA, Chen M, Kelly DP, Holloszy JO. Adaptations of skeletal muscle to exercise: rapid increase in the transcriptional coactivator PGC-1. FASEB J. 2002 Dec;16(14):1879-86. doi: 10.1096/fj.02-0367com.
PubMed 12468452Koopman R, Manders RJ, Zorenc AH, Hul GB, Kuipers H, Keizer HA, van Loon LJ. A single session of resistance exercise enhances insulin sensitivity for at least 24 h in healthy men. Eur J Appl Physiol. 2005 May;94(1-2):180-7. doi: 10.1007/s00421-004-1307-y. Epub 2005 Mar 11.
PubMed 15761746Silveira AP, Bentes CM, Costa PB, Simao R, Silva FC, Silva RP, Novaes JS. Acute effects of different intensities of resistance training on glycemic fluctuations in patients with type 1 diabetes mellitus. Res Sports Med. 2014;22(1):75-87. doi: 10.1080/15438627.2013.852096.
PubMed 24392773Davey RJ, Howe W, Paramalingam N, Ferreira LD, Davis EA, Fournier PA, Jones TW. The effect of midday moderate-intensity exercise on postexercise hypoglycemia risk in individuals with type 1 diabetes. J Clin Endocrinol Metab. 2013 Jul;98(7):2908-14. doi: 10.1210/jc.2013-1169. Epub 2013 Jun 18.
PubMed 23780373Tonoli C, Heyman E, Roelands B, Buyse L, Cheung SS, Berthoin S, Meeusen R. Effects of different types of acute and chronic (training) exercise on glycaemic control in type 1 diabetes mellitus: a meta-analysis. Sports Med. 2012 Dec 1;42(12):1059-80. doi: 10.1007/BF03262312.
PubMed 23134339Egan AM, Mahmood WA, Fenton R, Redziniak N, Kyaw Tun T, Sreenan S, McDermott JH. Barriers to exercise in obese patients with type 2 diabetes. QJM. 2013 Jul;106(7):635-8. doi: 10.1093/qjmed/hct075. Epub 2013 Mar 23.
PubMed 23525164Bautista L, Reininger B, Gay JL, Barroso CS, McCormick JB. Perceived barriers to exercise in Hispanic adults by level of activity. J Phys Act Health. 2011 Sep;8(7):916-25. doi: 10.1123/jpah.8.7.916.
PubMed 21885882
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Snacks and Glutamine to Improve Glucose Control in Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03199638
- Acronym / sponsor ID
- Nemours IRB #790908
- Conditions
- Diabetes Mellitus, Type 1, Autoimmune Diseases, Diabetes Mellitus, Endocrine System Diseases, Glucose Metabolism Disorders, Immune System Diseases
- Keywords
- Continuous Glucose Monitoring, Children, Exercise, Glycated hemoglobin, Adolescents, Insulin sensitivity, Glutamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 27 Jun 2017 (actual)
- Results
- Posted 14 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will assess the feasibility and efficacy of the use of exercise and dietary supplementation with a non essential amino acid - glutamine - a component of most protein supplements, on the regulation of plasma glucose homeostasis in a clinical setting of children with type 1 diabetes (T1D). The study specifically targets patients in puberty as this period is associated with a physiological decline in insulin sensitivity, the latter often associated with poor control. Although physical exercise has long been known to exert beneficial effects on metabolism, lack of time is the most common reason perceived as preventing the performance of exercise in both healthy and diabetic subjects. In earlier studies, the investigators showed that oral supplementation with glutamine, a non essential amino acid given prior to exercise decreases overnight post-exercise blood glucose in adolescents with T1D. Hence, the objective of the current study is to investigate if a novel way of exercising, such as performing 6 short bouts of just 1 min each of intense exercise ('exercise snacks') 30 min before meals, with or without glutamine, improves glycemic control in adolescents with T1D. Designing innovative ways to improve diabetes control in adolescents is highly desirable. The specific aim of the project is to determine whether the sustained use of the proposed exercise snacks with or without glutamine results in diminished glycemic variability and/or improved glucose control
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| an exercise group | Experimental | Behavioral: Exercisein 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); |
| an exercise + glutamine group | Experimental | Drug: Glutamine vs. Placebo, Behavioral: Exercisein 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 |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (18 listed)
- Type 1 diabetes for >12 months
- Age between 13 and 19 years
- Males and females at Tanner stage 4 and 5
- All insulin programs, including intermediate,short acting insulin, Lantus, Detemir and short acting insulin or insulin pump therapy.
- Weight of 40 kilograms or higher.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glutamine vs. Placebooral supplementation with either glutamine or placebo twice daily for 3 months | Drug | an exercise + glutamine group |
| Exerciseshort bouts of exercise ('exercise snacks') 3 times daily for 3 months | Behavioural | an exercise + glutamine group, an exercise group |
Primary outcome
HbA1c, Glycated Hemoglobin
Time frame: baseline vs. at 3 months
change in glycated hemoglobin
6 secondary outcomes
Change in the Mean Amplitude of Glycemic Excursions (MAGE)
Time frame: before vs. at 3 months
Change in Percent of Blood Glucose (BG) Within Target
Time frame: baseline vs. at 3 months
Percent of BG <70 mg/dL
Time frame: baseline vs. at 3 months
Percent Blood Glucose (BG) >180
Time frame: baseline vs. at 3 months
Insulin Dose
Time frame: baseline vs. at 3 months
Insulin Sensitivity Score (ISS)
Time frame: baseline vs. at 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 2950219Bloch CA, Clemons P, Sperling MA. Puberty decreases insulin sensitivity. J Pediatr. 1987 Mar;110(3):481-7. doi: 10.1016/s0022-3476(87)80522-x.
- Results publication: PubMed 8023918Caprio S, Cline G, Boulware S, Permanente C, Shulman GI, Sherwin RS, Tamborlane WV. Effects of puberty and diabetes on metabolism of insulin-sensitive fuels. Am J Physiol. 1994 Jun;266(6 Pt 1):E885-91. doi: 10.1152/ajpendo.1994.266.6.E885.
- Results publication: PubMed 3523245Amiel SA, Sherwin RS, Simonson DC, Lauritano AA, Tamborlane WV. Impaired insulin action in puberty. A contributing factor to poor glycemic control in adolescents with diabetes. N Engl J Med. 1986 Jul 24;315(4):215-9. doi: 10.1056/NEJM198607243150402.
- Results publication: PubMed 8487645Arslanian S, Heil BV, Kalhan SC. Hepatic insulin action in adolescents with insulin-dependent diabetes mellitus: relationship with long-term glycemic control. Metabolism. 1993 Mar;42(3):283-90. doi: 10.1016/0026-0495(93)90075-y.
- Results publication: PubMed 23899560Richter EA, Hargreaves M. Exercise, GLUT4, and skeletal muscle glucose uptake. Physiol Rev. 2013 Jul;93(3):993-1017. doi: 10.1152/physrev.00038.2012.
- Results publication: PubMed 640298Wahren J, Felig P, Hagenfeldt L. Physical exercise and fuel homeostasis in diabetes mellitus. Diabetologia. 1978 Apr;14(4):213-22. doi: 10.1007/BF01219419. No abstract available.
- Results publication: PubMed 2159218Goodyear LJ, King PA, Hirshman MF, Thompson CM, Horton ED, Horton ES. Contractile activity increases plasma membrane glucose transporters in absence of insulin. Am J Physiol. 1990 Apr;258(4 Pt 1):E667-72. doi: 10.1152/ajpendo.1990.258.4.E667.
- Results publication: PubMed 1987792Wasserman DH, Geer RJ, Rice DE, Bracy D, Flakoll PJ, Brown LL, Hill JO, Abumrad NN. Interaction of exercise and insulin action in humans. Am J Physiol. 1991 Jan;260(1 Pt 1):E37-45. doi: 10.1152/ajpendo.1991.260.1.E37.
- Results publication: PubMed 12468452Baar K, Wende AR, Jones TE, Marison M, Nolte LA, Chen M, Kelly DP, Holloszy JO. Adaptations of skeletal muscle to exercise: rapid increase in the transcriptional coactivator PGC-1. FASEB J. 2002 Dec;16(14):1879-86. doi: 10.1096/fj.02-0367com.
- Results publication: PubMed 15761746Koopman R, Manders RJ, Zorenc AH, Hul GB, Kuipers H, Keizer HA, van Loon LJ. A single session of resistance exercise enhances insulin sensitivity for at least 24 h in healthy men. Eur J Appl Physiol. 2005 May;94(1-2):180-7. doi: 10.1007/s00421-004-1307-y. Epub 2005 Mar 11.
- Results publication: PubMed 24392773Silveira AP, Bentes CM, Costa PB, Simao R, Silva FC, Silva RP, Novaes JS. Acute effects of different intensities of resistance training on glycemic fluctuations in patients with type 1 diabetes mellitus. Res Sports Med. 2014;22(1):75-87. doi: 10.1080/15438627.2013.852096.
- Results publication: PubMed 23780373Davey RJ, Howe W, Paramalingam N, Ferreira LD, Davis EA, Fournier PA, Jones TW. The effect of midday moderate-intensity exercise on postexercise hypoglycemia risk in individuals with type 1 diabetes. J Clin Endocrinol Metab. 2013 Jul;98(7):2908-14. doi: 10.1210/jc.2013-1169. Epub 2013 Jun 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Darmaun, PhD, MD principal investigator
Nemours Children's Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Diabetes Mellitus, Type 1 and Autoimmune Diseases, run by Nemours Children's Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c, Glycated Hemoglobin (time frame: baseline vs. at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03199638, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.