Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes A Randomized Crossover Study

NCT04089462 | Completed

• 1 other identifier: H-19035830
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

According to the Standards of Medical Care in Diabetes by the American Diabetes Association, people with diabetes should aim for 30 minutes of moderate-to-vigorous intensity aerobic exercise at least 5 days a week or a total of 150 minutes per week and doing some type of strength training at least 2 times per week in addition to aerobic activity. However, the effects of different forms and intervals of exercise on glycemic control are not well established. Exercise increases the risk of hypoglycemia both during and several hours after exercise. There are several strategies to avoid hypoglycemia during exercise. The most common strategy is to reduce insulin and to take carbohydrates before the exercise starts. Short-acting insulin analogs have a duration of approximately four hours, thus reductions need to be planned and done well in advance before the exercise starts. Since different types of exercise (aerobic, strength training or high intensity training) affect blood glucose in different ways and most exercise sessions include a combination of the types, these strategies are often associated with difficulties in obtaining stable blood glucose. The American Diabetes Association guidelines do not explicitly recommend a daily workout routine but outline recommendations for weekly amounts of exercise as there is currently insufficient evidence on the ideal timing, frequency and duration of exercise for preventing hypoglycemia. Hypothesis: in people with type 1 diabetes, time in hypoglycemia can be reduced if exercise is performed daily over five consecutive days compared to the same total amount of exercise performed at 2 days with at least 2 days interval. Aim: to evaluate the impact of the same total amount of exercise split into either five consecutive sessions or two sessions with at least 2 days in between on percentage of time spent in hypoglycemia and other glycemic parameters in people with type 1 diabetes.

Conditions

Diabetes Mellitus, Type 1; Insulin Hypoglycemia

Keywords

Exercise; Insulin pump; Diabetes Mellitus, Type 1; Guidelines

Outcome Measures

Primary Outcomes (1)

• Percentage of time spent in the hypoglycemic range (CGM <3.9 mmol/l)

  Intention-to-treat analysis (ITT).

  The primary intervention period from 06:00h study day 1 - 06:00h study day 6 (ITT)

Secondary Outcomes (105)

• Percentage of time spent in the hypoglycemic range (CGM <3.9 mmol/l)

  Primary intervention period from 06:00h study day 1 - 06:00h study day 6 PP

• Percentage of time spent in the alert and clinical hypoglycemic range

  Study day 1: The day when the first exercise session is performed and registered.

• Percentage of time spent in the alert and clinical hypoglycemic range

  Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)

• Percentage of time spent in the alert and clinical hypoglycemic range

  Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).

• Percentage of time spent in the alert and clinical hypoglycemic range

  Day time: 06:00-22:00h from during study day 1 to study day 6.

Study Arms (2)

1. "Five sessions per period" - "Two sessions per period"

OTHER

Behavioral: "Five sessions per period" - "Two sessions per period"

2. "Two sessions per period" - "Five sessions per period"

OTHER

Behavioral: "Two sessions per period" - "Five sessions per period"

Interventions

"Five sessions per period" - "Two sessions per period" BEHAVIORAL

Period 1: 5 exercise sessions on 5 consecutive days (4 min anaerobic exercise and 30 min aerobic exercise per session) Period 2: 2 exercise sessions within a 5-day period (10 min anaerobic exercise and 75 min aerobic exercise per session)

1. "Five sessions per period" - "Two sessions per period"

"Two sessions per period" - "Five sessions per period" BEHAVIORAL

Period 1: 2 exercise sessions within a 5-day period (10 min anaerobic exercise and 75 min aerobic exercise per session) Period 2: 5 exercise sessions on 5 consecutive days (4 min anaerobic exercise and 30 min aerobic exercise per session)

2. "Two sessions per period" - "Five sessions per period"

Eligibility Criteria

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

You may qualify if:

• Type 1 Diabetes ≥ 2 year
• Insulin pump ≥ 1 year.
• Use of carbohydrate counting and the insulin pump bolus calculator for all meals

You may not qualify if:

• Use of anti-diabetic medicine (other than insulin), per oral or injected corticosteroids or other drugs affecting glucose metabolism during the intervention period or within 30 days prior to study start
• Known or suspected alcohol or drug abuse
• Other concomitant medical or psychological condition that according to the investigator's assessment makes the participant unsuitable for study participation
• Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
• Inability to understand the participants' information and to give informed consent
• Chronic use or unable to stop acetaminophen (paracetamol) use
• Allergy to the patch of CGM
• Hypoglycemia unawareness, quantified by Pedersen-Bjergaard
• Severe hypoglycemia within the last year
• Vigorous-intensity exercise for more than 60 minutes on 3 days or more per week

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead

Study Sites (1)

Steno Diabetes Center Copenhagen

Gentofte Municipality, 2820, Denmark

Location

Related Publications (1)

• Steineck IIK, Ranjan AG, Schmidt S, Norgaard K. Time spent in hypoglycemia is comparable when the same amount of exercise is performed 5 or 2 days weekly: a randomized crossover study in people with type 1 diabetes. BMJ Open Diabetes Res Care. 2021 Jan;9(1):e001919. doi: 10.1136/bmjdrc-2020-001919.

  PMID: 33509935 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Isabelle IK Steineck, MD

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An open-labelled randomized controlled crossover study will be performed. The participants will go through the following elements: 1. Screening day 2. Run-in period 3. Intervention period 4. Wash-out period 5. Intervention period

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 13, 2019
• Study Start: September 30, 2019
• Primary Completion: October 15, 2020
• Study Completion: January 1, 2021
• Last Updated: September 28, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 21 oktober 2020

Locations

DK (1)