NCT02208115

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 4, 2014

Completed
Last Updated

August 4, 2014

Status Verified

August 1, 2014

Enrollment Period

Same day

First QC Date

July 25, 2014

Last Update Submit

August 1, 2014

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes MellitusExerciseAppetite

Outcome Measures

Primary Outcomes (1)

  • Acute subjective appetite responses

    Subjective appetite ratings via Visual Analogue Scales

    4 hours post-exercise

Study Arms (2)

Meal composition - High GI

EXPERIMENTAL

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

Dietary Supplement: Meal composition - Low versus high GI.

Meal composition - Low GI

EXPERIMENTAL

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

Dietary Supplement: Meal composition - Low versus high GI.

Interventions

Meal composition - Low versus high GI.DIETARY_SUPPLEMENT
Meal composition - High GIMeal composition - Low GI

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Facility, Royal Victoria Infirmary

Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 25733632DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Motor Activity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • Daniel J West, PhD

    Northumbria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2014

First Posted

August 4, 2014

Study Start

November 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

August 4, 2014

Record last verified: 2014-08

Locations

GB(1)