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Post-exercise Appetite Responses in Type 1 Diabetes

Primary Purpose

Type 1 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Meal composition - Low versus high GI.

About this trial

This is an interventional basic science trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes Mellitus, Exercise, Appetite

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Clinical Research Facility, Royal Victoria Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Meal composition - High GI

Meal composition - Low GI

Arm Description

Changing the glycaemic index of the meal consumed after exercise (High GI versus Low GI).

Outcomes

Primary Outcome Measures

Acute subjective appetite responses

Subjective appetite ratings via Visual Analogue Scales

Secondary Outcome Measures

Full Information

NCT ID

NCT02208115

First Posted

July 25, 2014

Last Updated

August 1, 2014

Sponsor

Northumbria University

Collaborators

Newcastle University

1. Study Identification

Unique Protocol Identification Number

NCT02208115

Brief Title

Post-exercise Appetite Responses in Type 1 Diabetes

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northumbria University

Collaborators

Newcastle University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes Mellitus, Exercise, Appetite

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Meal composition - High GI

Arm Type

Experimental

Arm Description

Changing the glycaemic index of the meal consumed after exercise (High GI versus Low GI).

Arm Title

Meal composition - Low GI

Arm Type

Experimental

Arm Description

Changing the glycaemic index of the meal consumed after exercise (High GI versus Low GI).

Intervention Type

Dietary Supplement

Intervention Name(s)

Meal composition - Low versus high GI.

Primary Outcome Measure Information:

Title

Acute subjective appetite responses

Description

Subjective appetite ratings via Visual Analogue Scales

Time Frame

4 hours post-exercise

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel J West, PhD

Organizational Affiliation

Northumbria University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Research Facility, Royal Victoria Infirmary

City

Newcastle upon Tyne

State/Province

Tyne and Wear

ZIP/Postal Code

NE1 4LP

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

25733632

Citation

Campbell MD, Gonzalez JT, Rumbold PL, Walker M, Shaw JA, Stevenson EJ, West DJ. Comparison of appetite responses to high- and low-glycemic index postexercise meals under matched insulinemia and fiber in type 1 diabetes. Am J Clin Nutr. 2015 Mar;101(3):478-86. doi: 10.3945/ajcn.114.097162. Epub 2014 Dec 31.

Results Reference

derived

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Post-exercise Appetite Responses in Type 1 Diabetes

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