CHO-loading Before and High Intermittent CHO-intake During Physical Exercise in T1D

October 25, 2018 updated by: Örebro University, Sweden

Carbohydrate Loading Before and Intermittent High Carbohydrate Intake During Prolonged Physical Exercise in Individuals With Type 1 Diabetes is Associated With Good Glucose Control

Prolonged physical exercise (PE) is a challenge in type 1 diabetes with an increased incidence of both hypoglycemia and hyperglycemia.

The purpose was to evaluate the impact of two consecutive days of carbohydrate (CHO) loading, followed by high intermittent CHO-intake during prolonged PE, facilitated by a proactive use of Real-Time Continuous Glucose Monitoring (rtCGM), on glucose control in individuals with type 1 diabetes.

Ten physically active individuals with type 1 diabetes were invited to participate in a 3-day long sports camp with the objective to evaluate CHO-loading and high intermittent CHO-intake during prolonged PE. 1.5 months later the same procedure was evaluated during a 90 km cross-country skiing race. Participants were instructed to act proactively using rtCGM with predictive alerts set for high and low glucose values to maintain sensor glucose values within target range, defined as 72-180 mg/dl (4-10 mmol/l).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a descriptive, single arm, non-randomized interventional study. The intervention consisted of carbohydrate loading prior to and intermittent high carbohydrate intake during physical exercise and a proactive use of Real-Time Continuous Glucose Monitoring (rtCGM) to achieve and maintain glucose control.

Central Contact Person Stig A Mattsson, dietician PhD student Phone: +46702047759 E-mail: stigmattsson@live.com

IPD Sharing Statement No: There is not a plan to make IPD available.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

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

All

Description

Inclusion criteria:

  • age 18-50 years
  • type 1 diabetes
  • diabetes duration >1 year
  • exercising regularly ≥3 workout/week
  • previous experience from cross-country skiing

Exclusion Criteria:

  • A1c 8.6% NGSP (70 mmol/mol IFCC)
  • proliferative retinopathy
  • known nephropathy
  • cardiac failure
  • following a low-carbohydrate diet.

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Descriptive, single arm, interventional study
The intervention consisted of carbohydrate loading prior to and intermittent high carbohydrate intake during physical exercise and a proactive use of Real-Time Continuous Glucose Monitoring (rtCGM) to achieve and maintain glucose control
Other: Carbohydrate loading and high intermittent carbohydrate intake during physical exercise
The intervention consisted of carbohydrate loading prior to and intermittent high carbohydrate intake during PE and a proactive use of Real-Time Continuous Glucose Monitoring (rtCGM) to achieve and maintain glucose control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percentage of the glucose values spent in target range, defined as 72-180 mg/dl.
Time Frame: Through 48 hours of carbohydrate loading and an average of 6.5 hours of cross-country skiing.
Through 48 hours of carbohydrate loading and an average of 6.5 hours of cross-country skiing.

Collaborators and Investigators

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

Sponsor

Örebro University, Sweden

Investigators

  • Principal Investigator: Johan Jendle, professor, Institute of Medical Sciences, Örebro University, 701 82, Örebro, Sweden

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 (Actual)

January 20, 2016

Primary Completion (Actual)

March 18, 2016

Study Completion (Actual)

March 25, 2016

Study Registration Dates

First Submitted

October 18, 2018

First Submitted That Met QC Criteria

October 25, 2018

First Posted (Actual)

October 26, 2018

Study Record Updates

Last Update Posted (Actual)

October 26, 2018

Last Update Submitted That Met QC Criteria

October 25, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr:2012/159

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will not share participants' data with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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