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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
Örebro University, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 18, 2018
    Last Updated
    October 25, 2018
    Sponsor
    Örebro University, Sweden
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    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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