Post-exercise Insulin Reductions in Type 1 Diabetes

NCT01531855 | Completed DMC

• 1 other identifier: west-walker1
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesise that reducing rapid-acting insulin dose after exercise will help prevent Type 1 diabetes individuals experiencing hypoglycaemia.

Conditions

Type 1 Diabetes

Keywords

T1DM, Exercise

Outcome Measures

Primary Outcomes (1)

• 24 hour blood glucose area under the curve

  24 hour, post-exercise, glucose area under the curve.

  24 hours

Secondary Outcomes (1)

• Ketogenesis

  60 minutes before and 24 hours post-exercise

Study Arms (1)

Insulin dose

OTHER

Reducing rapid-acting insulin dose (insulin aspart or lispro) after exercise.

Other: Reducing post-exercise rapid-acting insulin (insulin lispro or aspart) dose

Interventions

Reducing post-exercise rapid-acting insulin (insulin lispro or aspart) dose OTHER

Dosage after exercise

Insulin dose

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• T1DM,
• Male,
• basal-bolus regimen (insulin glargine / detemir with insulin lispro / aspart),
• HbA1c \< 9.9%,
• aged 18-50.

You may not qualify if:

• HbA1c \> 10%,
• not treated with basal-bolus (insulin glargine / detemir with insulin lispro / aspart),
• aged \<18 \> 50.

Sponsors & Collaborators

• Northumbria University: lead
• Diabetes UK: collaborator

Study Sites (1)

Clinical Research Facility

Newcaslte Upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom

Location

Related Publications (3)

• West DJ, Morton RD, Bain SC, Stephens JW, Bracken RM. Blood glucose responses to reductions in pre-exercise rapid-acting insulin for 24 h after running in individuals with type 1 diabetes. J Sports Sci. 2010 May;28(7):781-8. doi: 10.1080/02640411003734093.

  PMID: 20496226 BACKGROUND

• Campbell MD, Walker M, Trenell MI, Luzio S, Dunseath G, Tuner D, Bracken RM, Bain SC, Russell M, Stevenson EJ, West DJ. Metabolic implications when employing heavy pre- and post-exercise rapid-acting insulin reductions to prevent hypoglycaemia in type 1 diabetes patients: a randomised clinical trial. PLoS One. 2014 May 23;9(5):e97143. doi: 10.1371/journal.pone.0097143. eCollection 2014.

  PMID: 24858952 DERIVED

• Campbell MD, Walker M, Trenell MI, Jakovljevic DG, Stevenson EJ, Bracken RM, Bain SC, West DJ. Large pre- and postexercise rapid-acting insulin reductions preserve glycemia and prevent early- but not late-onset hypoglycemia in patients with type 1 diabetes. Diabetes Care. 2013 Aug;36(8):2217-24. doi: 10.2337/dc12-2467. Epub 2013 Mar 20.

  PMID: 23514728 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity

Interventions

Insulin Lispro; Insulin Aspart

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Daniel J West

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: February 13, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 4, 2014

Record last verified: 2014-08

Locations

GB (1)