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

Diabetes Mellitus, Type 1 Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03722225
• Other study ID #: Dnr:2012/159
• Status: Completed
• Phase: N/A
• Start date: January 20, 2016
• Est. completion date: March 25, 2016

Study information

• Verified date: October 2018
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 25, 2016
• Est. primary completion date: March 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Örebro University, Sweden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of the glucose values spent in target range, defined as 72-180 mg/dl.		Through 48 hours of carbohydrate loading and an average of 6.5 hours of cross-country skiing.