The Importance of Meal Composition on Preventing Exercise-induced Hypoglycemia in People With Type 1 Diabetes.

NCT04472962 | Completed DMC

• 1 other identifier: H-20007316
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a clinical, randomized, crossover study. The study investigates the effect of a low-carbohydrate-high-protein pre-exercise meal on preventing exercise-induced hypoglycemia in people with type 1 diabetes. The hypothesis is that intake of a low-carbohydrate-high-protein meal can reduce the duration and depth of hypoglycemia during and after exercise in people with type 1 diabetes compared with an isocaloric high-carbohydrate-low-protein meal with identical fat content. The study will contribute with new knowledge about importance of meal composition on preventing exercise-induced hypoglycemia.

Conditions

Type 1 Diabetes

Keywords

Exercise; Nutrition; Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• The area over the curve (AOC).

  The primary outcome measure is the AOC for plasma glucose (PG) \< 3.9 mmol/L during the in-clinic period assessed by YSI (Yellow Spring Instruments 2900 STAT Plus). The AOC is the area, which extends from the plasma glucose curve to the limit for hypoglycemia \< 3.9 mmol/l.

  7 hours.

Secondary Outcomes (44)

• Time spent < 3.9 mmol/l during in-clinic period, home period and overall study period assessed by CGM.

  7, 17 and 24 hours respectively.

• Time spent < 3.9 mmol/l during in-clinic period assessed by YSI.

  7 hours.

• Time spent 3.0-3.8 mmol/l during in-clinic period, home period, and overall study period assessed by CGM.

  7, 17 and 24 hours respectively.

• Time spent 3.0-3.8 mmol/l during in-clinic period assessed by YSI.

  7 hours.

• Time spent < 3.0 mmol/l during in-clinic period, home period, and overall study period assessed by CGM.

  7, 17 and 24 hours respectively.

Study Arms (2)

Low-carbohydrate-high-protein pre-exercise meal

ACTIVE COMPARATOR

Other: Pre-exercise meal

High-carbohydrate-low-protein pre-exercise meal

ACTIVE COMPARATOR

Other: Pre-exercise meal

Interventions

Pre-exercise meal OTHER

Mixed meal with low-carbohydrate-high-protein content

Low-carbohydrate-high-protein pre-exercise meal

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years.
• Type 1 diabetes ≥ 5 years.
• Insulin pump use ≥ 1 year.
• Use of flash glucose monitoring (FGM) or continuous glucose monitoring (CGM) ≥ 3 months.
• Body mass index 18.5-30 kg/m2.
• HbA1c ≤ 64 mmol/mol (8.0%).
• Self-reported hypoglycemia awareness
• Ability to carbohydrate count for all meals.
• Familiarity with the insulin pump bolus calculator for all meals.
• Moderate to vigorous level of physical activity

You may not qualify if:

• Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start.
• Use of Metronic Minimed 670G insulin pump system.
• Allergy to paracetamol or nuts
• Females who are pregnant, breast-feeding or intend to become pregnant.
• Heart disease.
• Severe asthma.
• Other concomitant medical or psychological condition that according to the investigator's assessment makes the individual unsuitable for study participation.

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• Swansea University: collaborator

Study Sites (1)

Steno Diabetes Center Copenhagen

Gentofte Municipality, 2820, Denmark

Location

Related Publications (2)

• Kristensen KB, Ranjan AG, McCarthy OM, Holst JJ, Bracken RM, Norgaard K, Schmidt S. Effects of a Low-Carbohydrate-High-Protein Pre-Exercise Meal in Type 1 Diabetes-a Randomized Crossover Trial. J Clin Endocrinol Metab. 2023 Dec 21;109(1):208-216. doi: 10.1210/clinem/dgad427.

  PMID: 37463489 DERIVED

• McCarthy OM, Kristensen KB, Christensen MB, Schmidt S, Ranjan AG, Nicholas C, Bain SC, Norgaard K, Bracken R. Metabolic and physiological responses to graded exercise testing in individuals with type 1 diabetes using insulin pump therapy. Diabetes Obes Metab. 2023 Mar;25(3):878-888. doi: 10.1111/dom.14938. Epub 2023 Jan 3.

  PMID: 36482870 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity; Hypoglycemia

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 16, 2020
• Study Start: August 14, 2020
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: February 15, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)