Carbohydrate and Insulin Requirements During Prolonged Fasted Exercise

NCT04383015 | Completed

• 1 other identifier: e2018-306
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the time spent in glucose target range (4.0-10.0 mmol/L) during exercise and in recovery using three different management strategies for prolonged aerobic exercise: A) carbohydrate dose of 0.3g/kg/hr; B) A 50 percent basal rate reduction, performed 90-minutes in advance of exercise for the duration of the activity; and C) A 50 percent basal rate reduction, performed at exercise onset, with carbohydrate dose of 0.3g/kg/hr

Conditions

Type 1 Diabetes

Keywords

Physical Activity; Exercise; Carbohydrates; Hypoglycemia; Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

• Time in glucose target range during exercise intervention

  The primary outcome measurement is to determine which strategy had the best time in blood glucose target range (4.0-10.0 mmol/L) during the prolonged exercise

  140 minutes

Secondary Outcomes (1)

• Recovery Interstitial Glucose

  24 hours

Study Arms (3)

Carbohydrate (CHO)-only

OTHER

Carbohydrate dose of 0.3g/kg/hr given every 30 minutes of exercise if blood glucose is in range with usual basal insulin infusion

Other: Exercise strategies

50 Percent Basal Rate Reduction (BRR)

OTHER

A 50 percent basal rate reduction set 90-minutes pre-exercise and throughout exercise

Other: Exercise strategies

Combo

OTHER

The combination of a 50 percent basal rate reduction and carbohydrate dose of 0.3g/kg/hr (given every 30 minutes) both at exercise onset

Other: Exercise strategies

Interventions

Exercise strategies OTHER

Strategies for exercise in type 1 diabetes to maintain glucose control

50 Percent Basal Rate Reduction (BRR); Carbohydrate (CHO)-only; Combo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of presumed autoimmune type 1 diabetes
• Last HbA1c ≤ 9.9 percent
• Age: 17+ years
• Duration of T1D: ≥ 1.5 years
• Using insulin pump therapy: ≥3 months (at least 0.25 units of insulin per kilogram of body mass)
• In good general health with no conditions that could impact the outcome of the trial
• Willing to adhere to the protocol requirements for the duration of the study

You may not qualify if:

• Physician diagnosis of active diabetic retinopathy that could be worsened by exercise
• Physician diagnosis of peripheral neuropathy or autonomic neuropathy
• Medications:
• Beta-blockers
• Agents that affect hepatic glucose production (xanthine derivatives)
• Pramlintide
• Any other hypoglycemic agent
• Participation in other studies involving the administration of an investigational drug or device during the duration of the current study
• Severe hypoglycemia in the last 3 months, defined as the individual requiring third party assistance or hospitalization

Sponsors & Collaborators

• York University: lead
• Insulet Corporation: collaborator

Study Sites (1)

York University

Toronto, Ontario, M3J1P3, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Michael Riddell, PhD

  York University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients with type 1 diabetes on insulin pump therapy will remain on their usual insulin regimen. However, we are testing percent basal rate reductions during exercise (50 percent reduction) with or without carbohydrate feeding.

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 11, 2020
• Study Start: October 31, 2018
• Primary Completion: October 16, 2019
• Study Completion: October 17, 2019
• Last Updated: May 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)