Post-exercise Appetite Responses in Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:

A Comparison of the Appetite Responses to High and Low Glycemic Index Post-exercise Meals Under Matched Insulinemia and Fibre in Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02208115
• Other study ID #: West-Walker3.1
• Status: Completed
• Phase: N/A
• First received: July 25, 2014
• Last updated: August 1, 2014
• Start date: November 2013
• Est. completion date: November 2013

Study information

• Verified date: August 2014
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesise that manipulating the glycaemic index of the meal after exercise will influence the acute appetite responses of Type 1 diabetes individuals

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Aged between 18-50 years old (male or female).

• Free from any diabetes related complications (apart from mild background diabetic retinopathy).

• HbA1c <8.5%.

• Not taking any prescribed medication other than insulin, and treated with a stable insulin regimen composed of a combination of slow/long acting insulin (glargine or detemir) and fast-acting insulin analogues (lispro or aspart), for a minimum of 6 months before the start of the study.

• Demonstrate normal cardiac function in response to exercise.

Exclusion Criteria:

• Aged younger than 18, or older than 50 years.

• Suffering from, or diagnosed with a diabetes related complication (apart from mild background diabetic retinopathy).

• HbA1c >8.5%.

• Currently taking prescribed medication, and not currently treated with a stable basal bolus regimen composed of a combination glargine or detemir, and lispro or aspart for at least 6 months before the start of the study.

• Failure to demonstrate normal cardiopulmonary responses during exercise, or have a medical condition which could prevent completion of exercise or be exacerbated because of.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Dietary Supplement:
• Meal composition - Low versus high GI.

Locations

Country	Name	City	State
United Kingdom	Clinical Research Facility, Royal Victoria Infirmary	Newcastle upon Tyne	Tyne and Wear

Sponsors (2)

Lead Sponsor	Collaborator
Northumbria University	Newcastle University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute subjective appetite responses	Subjective appetite ratings via Visual Analogue Scales	4 hours post-exercise	No