Determining Circadian Metabolic and Behavioural Rhythms in Patients with and Without Type 2 Diabetes and Identifying the Relation to Hormone and Glucose Fluctuations, and Cognition

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The goal of the present clinical descriptive study is to characterize and quantify the potential hormonal chronobiological differences between individuals with type 2 diabetes (T2D) and healthy age and weight-matched controls as either circadian aligned or misaligned. The investigators hypothesize that individuals with T2D have a misaligned and different circadian rhythmicity of circadian biomarkers (melatonin and cortisol) than controls, and that this difference in turn is related to 24h hormonal fluctuations, behaviour, and metabolic-, cardiac-, and cognitive parameters. Participants will be asked to: * fill-out a diary on eating and sleeping habits for 30 days * wear an actigraphy and continuous glucose monitor for 10-14 days * stay overnight at the research facility, including continuous blood sampling and polysomnography

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 75
Healthy Volunteers: t
View:

⁃ Individuals with T2D:

• Informed and written consent.

• Clinically diagnosed diabetes mellitus type 2 for at least 5 years (diagnosed according to criteria of World Health Organization (WHO)).

• HbA1c \>53 mmol/mol

• Stable medical treatment for at least 8 weeks.

• Plasma haemoglobin ≥8.00 mmol/L (male) or ≥6.4 mmol/L (female).

• Male or female participants aged 50-75 years.

⁃ Healthy matched controls:

• Informed and written consent.

• Normal haemoglobin ≥8.00 mmol/L (male) or ≥6.4 mmol/L (female).

• Male or female participants aged 50-75 years.

Locations
Other Locations
Denmark
Steno Diabetes Center Copenhagen
RECRUITING
Herlev
Contact Information
Primary
Helena Z Wodschow, MD
helena.zander.wodschow.03@regionh.dk
+45 30313426
Backup
Jørgen Rungby, MD, DMSc
joergen.rungby@regionh.dk
+45 21686620
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2025-05-01
Participants
Target number of participants: 60
Treatments
Type 2 Diabetes
Individuals with type 2 diabetes
Controls
Individuals without type 2 diabetes matched on age and body mass index
Related Therapeutic Areas
Sponsors
Leads: Steno Diabetes Center Copenhagen
Collaborators: University Hospital Bispebjerg and Frederiksberg, Glostrup University Hospital, Copenhagen

This content was sourced from clinicaltrials.gov