The Impact of Macronutrient Composition on Glucose Dynamics in Persons With Type 1 Diabetes

NCT05268705 | Completed

• 1 other identifier: H-21042230
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, open-label, three-arm crossover study will be conducted. The aim of the study is to determine the effect of different isocaloric diet macronutrient compositions (High-carbohydrate-Low-fat-Low-protein (HCLFLP), Low-carbohydrate-High-fat-Low-protein (LCHFLP), Low-carbohydrate-Low-fat-High-protein (LCLFHP)) on plasma glucose dynamics in everyday life and during fasted exercise in persons with type 1 diabetes. Our hypothesis is that a HCLFLP diet reduce the decrease in plasma glucose from start to end of fasted exercise compared with a LCHFLP diet. Secondary a LCHFLP compared with a LCLFHP diet does not reduces the decrease in plasma glucose from start to end of fasted exercise. The current study will contribute with new knowledge about the importance of the compositions of a low-carbohydrate diet on glucose dynamics and the influence on plasma glucose during and after cycling in fasted state.

Conditions

type1diabetes

Keywords

Type 1 diabetes; Nutrition; Exercise; Insulin pump

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the difference between study arms in difference from start to end plasma glucose concentration during 45 min fasted cycling (assessed by YSI (Yellow Spring Instruments 2900 STAT Plus)).

  45 min

Secondary Outcomes (29)

• Mean CGM glucose level assessed by CGM during diet interventions

  7 days

• Time spent < 3.9 mmol/l assessed by CGM during diet interventions

  7 days

• Time spent < 3.0 mmol/l assessed by CGM during diet interventions

  7 days

• Time spent 3.9-10.0 mmol/l assessed by CGM during diet interventions

  7 days

• Time spent > 10.0 mmol/l assessed by CGM during diet interventions

  7 days

Study Arms (3)

High-carbohydrate-low-fat-low-protein diet

ACTIVE COMPARATOR

Other: 7-day diet

Low-carbohydrate-high-fat-low-protein diet

ACTIVE COMPARATOR

Other: 7-day diet

Low-carbohydrate-low-fat-high-protein diet

ACTIVE COMPARATOR

Other: 7-day diet

Interventions

7-day diet OTHER

The participants must follow a 7-day high-carbohydrate-low-fat-low-protein diet before the inclinic study visit at day 8. The in-clinic study visits are identical for all the three study arms.

High-carbohydrate-low-fat-low-protein diet

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Type 1 diabetes ≥ 5 years
• Insulin pump use ≥ 1 year
• Use of intermittently scanned continuous glucose monitoring (isCGM) or continuous glucose monitoring (CGM) ≥ 3 months
• HbA1c ≤ 69 mmol/mol (8.5%)
• Self-reported hypoglycemia awareness
• Exercising at least 30 minutes at moderate or vigorous intensity two times per week.

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 a hybrid closed-loop system
• Females who are pregnant, breast-feeding or intend to become pregnant during the study period
• Ischemic 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

Herlev, 2730, Denmark

Location

Related Publications (1)

• 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

Interventions

Diet

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Kirsten Nørgaard, Professor

  Steno Diabetes Center Copenhagen, Clinical Reseach, Diabetes Technology Research

  PRINCIPAL INVESTIGATOR

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: January 31, 2022
• First Posted: March 7, 2022
• Study Start: February 3, 2022
• Primary Completion: November 8, 2022
• Study Completion: November 8, 2022
• Last Updated: January 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)