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

NCT ID: NCT03722225

Last Updated: 2018-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-20

Study Completion Date

2016-03-25

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Carbohydrate loading and high intermittent carbohydrate intake during physical exercise

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Örebro University, Sweden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johan Jendle, professor

Role: PRINCIPAL_INVESTIGATOR

Institute of Medical Sciences, Örebro University, 701 82, Örebro, Sweden

References

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Mattsson S, Jendle J, Adolfsson P. Carbohydrate Loading Followed by High Carbohydrate Intake During Prolonged Physical Exercise and Its Impact on Glucose Control in Individuals With Diabetes Type 1-An Exploratory Study. Front Endocrinol (Lausanne). 2019 Aug 21;10:571. doi: 10.3389/fendo.2019.00571. eCollection 2019.

Reference Type DERIVED
PMID: 31496994 (View on PubMed)

Other Identifiers

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Dnr:2012/159

Identifier Type: -

Identifier Source: org_study_id

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