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

NCT03722225 | Completed

• 1 other identifier: Dnr:2012/159
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Descriptive, single arm, interventional study

EXPERIMENTAL

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

Interventions

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

Descriptive, single arm, interventional study

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Örebro University, Sweden: lead

Related Publications (1)

• 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.

  PMID: 31496994 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Diet, Carbohydrate Loading

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Johan Jendle, professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 26, 2018
• Study Start: January 20, 2016
• Primary Completion: March 18, 2016
• Study Completion: March 25, 2016
• Last Updated: October 26, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share