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Trial record 26 of 342 for:    high intensity | Canada

Optimal Insulin Correction Factor in Post- High Intensity Exercise Hyperglycemia in Adults With Type 1 Diabetes (FIT) (FIT)

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ClinicalTrials.gov Identifier: NCT03057470
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : February 20, 2017
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
LMC Diabetes & Endocrinology Ltd.

Brief Summary:
The overall objective of this study is to investigate the glycemic response of a 0%, 50%, 100% and 150% bolus insulin correction (based on personal insulin correction factor) of post-exercise hyperglycemia in physically active adults with type 1 diabetes (T1D) using multiple daily injections (MDI) in a controlled, but clinically representative, experimental setting.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: 50% bolus insulin correction Drug: 100% bolus insulin correction Drug: 150% bolus insulin correction Other: 0% bolus insulin correction Phase 4

Detailed Description:
FIT is an open-label, repeated measures cross-over study. The overall objective of this study is to investigate the glycemic response of a 0%, 50%, 100% and 150% bolus insulin correction (based on personal insulin correction factor) of post-exercise hyperglycemia in physically active adults with type 1 diabetes (T1D) using multiple daily injections (MDI) in a controlled, but clinically representative, experimental setting. Following a 2 week screening phase, patients will enter an 8 week transition to insulin glargine U300 (Toujeo®) if on another basal insulin, in order to optimize their insulin dose and determine their individual insulin correction factor. The final phase of the study is the intervention phase, which consists of 4 separate visits. At each visit, the patient will perform 15 minutes of high intensity exercise in the morning. If they become hyperglycemic following exercise (blood glucose >8.0 mmol/L), they will receive one of four insulin correction doses (0% 50%, 100%, or 150% of their usual correction factor) in a randomized order. They will be monitored in the clinical pharmacology unit by study staff for the rest of the day and overnight. The patient will wear a continuous glucose monitor (CGM) during each intervention visit. The primary outcome of the study is the greatest net reduction in plasma glucose (YSI) following a 50%, 100% and 150% bolus insulin correction of post-exercise hyperglycemia, compared to no bolus insulin correction. Key secondary outcomes include the mean time spent in post-exercise hyperglycemia (>8.0 mmol/L), post-exercise euglycemia (4.0-8.0 mmol/L) and post-exercise hypoglycaemia (≤ 3.9 mmol/L) within 180 minutes and 24 hours following bolus insulin correction.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimal Insulin Correction Factor in Post- High Intensity Exercise Hyperglycemia in Adults With Type 1 Diabetes: The FIT Study
Study Start Date : May 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 0% Bolus Insulin Correction
0% Bolus Insulin Correction
Other: 0% bolus insulin correction
Patients will receive no bolus insulin correction for post-exercise hyperglycemia

Active Comparator: 50% Bolus Insulin Correction
50% Bolus Insulin Correction
Drug: 50% bolus insulin correction
Patients will receive 50% of their usual bolus insulin correction for post-exercise hyperglycemia

Active Comparator: 100% Bolus Insulin Correction
100% Bolus Insulin Correction
Drug: 100% bolus insulin correction
Patients will receive 100% of their usual bolus insulin correction for post-exercise hyperglycemia

Active Comparator: 150% Bolus Insulin Correction
150% Bolus Insulin Correction
Drug: 150% bolus insulin correction
Patients will receive 150% of their usual bolus insulin correction for post-exercise hyperglycemia




Primary Outcome Measures :
  1. Reduction In Plasma Glucose (YSI) [ Time Frame: 147 days ]

Secondary Outcome Measures :
  1. Investigate Glycemic Response of a 0%, 50%, 100% and 150% Bolus Insulin Correction of Post-exercise Hyperglycemia Compared to no Bolus Insulin Correction [ Time Frame: 147 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Male or female
  • Clinical diagnosis of presumed autoimmune T1D
  • Age 18-55 years, inclusive
  • Duration of T1D ≥ 6 months
  • Using MDI therapy for at least 6 months
  • Fasting C-peptide value of < 0.7 ng/mL (0.23 nmol/L) at screening visit
  • Patient must be willing to undergo an 8-week run-in phase prior to the study period where they will be required to use MDI therapy at least 4 times per day, and switch from their usual basal insulin to insulin glargine U300
  • Exercise regularly: i.e. ≥ 30 minutes of moderate or vigorous aerobic activity ≥ 3 times/week for a minimum of 90 minutes weekly
  • VO2peak ≥32 ml/kg/min for females and ≥ 35 ml/kg/min for males
  • HbA1c between 6.0-9.0% inclusive at screening visit.
  • Insulin total daily dose (TDD) ≥ 30 U/day
  • In good general health with no known conditions that could influence the outcome of the trial, and in the judgement of the Investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations
  • Willing to adhere to the protocol requirements for the duration of the study

Exclusion Criteria

  • Pregnant or lactating
  • Active diabetic retinopathy (proliferative diabetic retinopathy, or vitreous haemorrhage in past 6 months) that could potentially be worsened by the exercise protocol
  • Any evidence of unstable cardiovascular disease, disorders or abnormalities as per physician's discretion. .
  • Currently following a very low calorie or other weight-loss diet which may impact glucose control and mask the primary and secondary outcome measures
  • More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months
  • Known hypoglycemia unawareness
  • Use of acetaminophen (Tylenol) during the run-in phase or study period
  • Medications other than insulin that might impact outcome measures:
  • Beta blockers
  • Agents that affect hepatic glucose production such as beta adrenergic agonists and antagonists, xanthine derivatives
  • Pramlintide
  • Any non-insulin diabetes therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057470


Contacts
Contact: Ronnie Aronson, MD 416-645-2929 aronsonresearch@LMC.ca
Contact: Saeideh Mayanloo, BSc 416-645-2929 ext 9330 saeideh.mayanloo@LMC.ca

Locations
Canada, Ontario
LMC Bayview Recruiting
Toronto, Ontario, Canada
Contact: Ronnie Aronson, MD    416-645-2929    torontoresearch@lmc.ca   
Sponsors and Collaborators
LMC Diabetes & Endocrinology Ltd.
Sanofi
Investigators
Principal Investigator: Ronnie Aronson, MD LMC Diabetes & Endocrinology

Publications:
1. Robertson K, Adolfsson P, Scheiner G, Hanas R, Riddell M. Exercise in children and adolescents with diabetes. Pediatric diabetes. 2009;10(Journal Article):154. 2. Wasserman DH, Zinman B. Exercise in individuals with IDDM. Diabetes Care. 1994;17(8):924-937. 3. Galassetti P, Riddell MC. Exercise and type 1 diabetes (T1DM). Compr Physiol. 2013;3(3):1309-1336. 4. Zaharieva DP, Riddell MC. Prevention of exercise-associated dysglycemia: a case study-based approach. Diabetes Spectr. 2015;28(1):55-62. 5. Pivovarov JA, Taplin CE, Riddell MC. Current perspectives on physical activity and exercise for youth with diabetes. Pediatr Diabetes. 2015. 6. Marliss EB, Vranic M. Intense exercise has unique effects on both insulin release and its roles in glucoregulation: implications for diabetes. Diabetes. 2002;51 Suppl 1:S271-283. 7. Fahey AJ, Paramalingam N, Davey RJ, Davis EA, Jones TW, Fournier PA. The effect of a short sprint on postexercise whole-body glucose production and utilization rates in individuals with type 1 diabetes mellitus. J Clin Endocrinol Metab. 2012;97(11):4193-4200. 8. Benbenek-Klupa T, Matejko B, Klupa T. Metabolic control in type 1 diabetes patients practicing combat sports: at least two-year follow-up study. Springerplus. 2015;4:133. 9. Iscoe KE, Riddell MC. Continuous moderate-intensity exercise with or without intermittent high-intensity work: effects on acute and late glycaemia in athletes with Type 1 diabetes mellitus. Diabetic Med. 2011;28(7):824-832. 10. Graveling AJ, Frier BM. Risks of marathon running and hypoglycaemia in Type 1 diabetes. Diabet Med. 2010;27(5):585-588. 11. Tanenberg RJ, Newton CA, Drake AJ. Confirmation of hypoglycemia in the

Responsible Party: LMC Diabetes & Endocrinology Ltd.
ClinicalTrials.gov Identifier: NCT03057470     History of Changes
Other Study ID Numbers: FIT
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only overall study data will be shared

Keywords provided by LMC Diabetes & Endocrinology Ltd.:
Diabetes
Exercise
Insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs