CHO-loading Before and High Intermittent CHO-intake During Physical Exercise in T1D
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Carbohydrate loading and high intermittent carbohydrate intake during physical exercise
Sponsored by
About this trial
This is an interventional other trial for Diabetes Mellitus, Type 1
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Descriptive, single arm, interventional study
Arm Description
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
Outcomes
Primary Outcome Measures
The percentage of the glucose values spent in target range, defined as 72-180 mg/dl.
Secondary Outcome Measures
Full Information
NCT ID
NCT03722225
First Posted
October 18, 2018
Last Updated
October 25, 2018
Sponsor
Örebro University, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT03722225
Brief Title
CHO-loading Before and High Intermittent CHO-intake During Physical Exercise in T1D
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 20, 2016 (Actual)
Primary Completion Date
March 18, 2016 (Actual)
Study Completion Date
March 25, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Örebro University, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model 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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Descriptive, single arm, interventional study
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Carbohydrate loading and high intermittent carbohydrate intake during physical exercise
Intervention Description
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 Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Jendle, professor
Organizational Affiliation
Institute of Medical Sciences, Örebro University, 701 82, Örebro, Sweden
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We will not share participants' data with other researchers.
Citations:
PubMed Identifier
31496994
Citation
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.
Results Reference
derived
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CHO-loading Before and High Intermittent CHO-intake During Physical Exercise in T1D
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