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Completed

NCT Number: NCT03722225

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

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).

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Key information

About this study

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: [email protected]

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carbohydrate loading and high intermittent carbohydrate intake during physical exercise

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 26, 2018
Registry last updated
Oct 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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