Post-exercise Appetite Responses in Type 1 Diabetes

August 1, 2014 updated by: Northumbria University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP
        • Clinical Research Facility, Royal Victoria Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Meal composition - High GI
Changing the glycaemic index of the meal consumed after exercise (High GI versus Low GI).
Dietary supplement: Meal composition - Low versus high GI.
Experimental: Meal composition - Low GI
Changing the glycaemic index of the meal consumed after exercise (High GI versus Low GI).
Dietary supplement: Meal composition - Low versus high GI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute subjective appetite responses
Time Frame: 4 hours post-exercise
Subjective appetite ratings via Visual Analogue Scales
4 hours post-exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northumbria University

Collaborators

Newcastle University

Investigators

  • Principal Investigator: Daniel J West, PhD, Northumbria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

July 25, 2014

First Submitted That Met QC Criteria

August 1, 2014

First Posted (Estimate)

August 4, 2014

Study Record Updates

Last Update Posted (Estimate)

August 4, 2014

Last Update Submitted That Met QC Criteria

August 1, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • West-Walker3.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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