Do "sugar Swings" Impact the Brain Function and the Eating Behaviors of People with Type 1 Diabetes

NCT05487534 | Recruiting

• 1 other identifier: MP-20-2023-6466
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

In type 1 diabetes, it is common to choose the food we eat according to the blood sugar level and the insulin dose and vice versa. Beyond the nutritional aspects, the relationship to food and the resulting eating behaviors can be a source of suffering. Also, it has been reported that one out of two people over 60 years of age living with type 1 diabetes has cognitive impairment. Changes in cognitive functions can have important implications for daily well-being, diet (e.g., the ability to modulate cravings), and treatment decisions to manage diabetes. One factor that can affect both eating behaviors and cognitive function is variation in blood glucose levels. This research aims to better understand the impact of glycemic variability in disordered eating behaviors and cognitive impairment, and its consequences on self-management skills in people with type 1 diabetes. The hypotheses are that i) higher glycemic variability is associated with higher disordered eating behaviors and poorer cognitive function in people with type 1 diabetes, and that differences exist between sexes, ii) higher disordered eating behaviors and poorer cognitive function are associated with lower self-management skills; and iii) cognitive impairment, interoception awareness and insulin resistance may mediate the relationship between glycemic variability and disordered eating behaviors. This research study will contribute to highlighting the consequences of blood sugar fluctuations, "sugar swings", in daily life, in particular the way they disrupt eating behaviors and brain function. A better understanding of the mechanisms involved could eventually allow for early detection and management of these problems. Our study will also seek to understand the patients' point of view, which will allow the design of appropriate and meaningful recommendations.

Conditions

Type 1 Diabetes

Keywords

Diabetes; Cognition; Eating behaviors; Glycemic variation; Blood glucose

Outcome Measures

Primary Outcomes (2)

• Eating Disorder examination (EDE-Q)

  To assess eating behaviors according to their glycemic variability.

  Day 1 (+/- 2 days)

• Glucose variability and insulin resistance (CGMS - 10 days)

  CGMS will be performed over a 10-day period using a DEXCOM G6 to separate participants into groups based on glycemic variation (i.e., a coefficient of variation \[CV\] \>36% over a 10-day CGMS) versus those with a low glucose variability (i.e., CV \<36%).

  Start at inclusion (Day 1 to Day 10)

Secondary Outcomes (33)

• Distress Diabetes Scale (T1-DDS)

  Inclusion

• Diabetes Behavior Ratting Scale (DBRS)

  Inclusion

• Generalized Anxiety Disorder (GAD-7)

  Inclusion

• Patient Health Questionnaire (PHQ-9)

  Inclusion

• Diabetes Numeracy Test (DNT-15)

  Inclusion

Study Arms (2)

Sugar Swing +

Patients with type 1 diabetes with a high glucose variability (i.e., a coefficient of variation \> 36% over a 10-day continuous glucose monitoring)

Other: Observational

Sugar Swing -

Patients with type 1 diabetes with low glucose variability (i.e., a coefficient of variation \< 36% over a 10-day continuous glucose monitoring)

Other: Observational

Interventions

Observational OTHER

The same self-reported questionnaires and cognitive tests will be completed by both groups. There is no intervention.

Sugar Swing +; Sugar Swing -

Eligibility Criteria

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

Study Population

Participants will be recruited through the endocrinology clinics of the CHU de Québec (approximately 1000 patients living with type 1 diabetes) and the Institut de recherches cliniques de Montréal (IRCM) (\>800 patients living with type 1 diabetes). We will also recruit through the BETTER registry, overseen by Dr. Rabasa-Lhoret and Dr. Brazeau (collaborators on the project) and co-funded by IRSC and JDRF: over 2000 people with type 1 diabetes are currently enrolled in the registry and 98% of participants have agreed to be contacted for future research studies. In case of recruitment difficulties, an announcement will also be made on social networks (such as Facebook).

You may qualify if:

• Type 1 diabetes (\> 12 months)
• Age between 18 and 65 years old
• % \< A1C \< 9% (to avoid potential severe eating disorder)

You may not qualify if:

• Type 2 diabetes or other form of diabetes; gastroparesis (clinical diagnosis);
• Recent (\< 6 months) major cardiovascular event (e.g. myocardial infarction, cerebrovascular accident, major revascularization)
• Recent (\< 12 weeks) severe hypoglycemia episodes (\<2.8 mmol/L or assistance from a third party)
• Recent (\< 12 weeks) changes in insulin type or delivery method
• Automated Insulin Delivery
• History of severe brain trauma, epilepsy, schizophrenia or bipolar disorders
• Inability to use a computer
• Incorrect vision or auditory problems

Sponsors & Collaborators

• Laval University: lead
• CHU de Quebec-Universite Laval: collaborator
• Institut de Recherches Cliniques de Montreal: collaborator
• Centre d'expertise Poids, Image et Alimentation (CEPIA): collaborator
• Institut universitaire de cardiologie et de pneumologie de Québec, University Laval: collaborator

Study Sites (2)

IRCM

Montreal, Canada

RECRUITING

CHU de Québec

Québec, Canada

RECRUITING

Related Publications (1)

• Iceta S, Sohier L, Begin C, Brazeau AS, Rabasa-Lhoret R, Gagnon C. Impact of glycemic variability on cognitive impairment, disordered eating behaviors and self-management skills in patients with type 1 diabetes: study protocol for a cross-sectional online study, the Sugar Swing study. BMC Endocr Disord. 2022 Nov 18;22(1):283. doi: 10.1186/s12902-022-01191-4.

  PMID: 36401237 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Feeding Behavior

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Sylvain Iceta, MD, PhD

  Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvain Iceta, MD, PhD

CONTACT

+1 (418) 656-8711; equipe.iceta@criucpq.ulaval.ca

Melissa Pelletier, M. Sc

CONTACT

+1 (418) 656-8711; equipe.iceta@criucpq.ulaval.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: August 4, 2022
• Study Start: April 26, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

CA (2)