Determining Circadian Metabolic and Behavioural Rhythms in Patients with and Without Type 2 Diabetes

NCT06243172 | Unknown

• 1 other identifier: H-22014311
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Type 2 Diabetes; Circadian Rhythm

Keywords

Type 2 Diabetes; Circadian Rhythm; Cognition; Sleep

Outcome Measures

Primary Outcomes (2)

• Melatonin oscillations (amplitude, peak, mesor, phase, period length (TAU))

  Blood samples

  24-hour in-hospital day, blood samples taken every third hour for 24 hours (9 timepoints in total)

• Cortisol oscillations (amplitude, peak, mesor, phase, period length (TAU))

  Blood samples

  24-hour in-hospital day, blood samples taken every third hour for 24 hours (9 timepoints in total)

Secondary Outcomes (20)

• Dim light melatonin onset

  24-hour in-hospital day, blood samples taken every hour from 18:00 until 00:00 (7 timepoints in total)

• Phase angle (time between dim light melatonin onset and sleep)

  24-hour in-hospital day, blood samples taken every hour from 18:00 until 00:00 (7 timepoints in total)

• Cortisol awakening response

  24-hour in-hospital day, blood samples taken at wake up, and 15-, 30-, and 60-minutes post-wake up

• Diary on sleeping habits

  30 days

• Diary on eating window

  30 days

Other Outcomes (4)

• Chronotype (diurnal preference)

  At screening

• Sleep apnea

  24-hour in-hospital day

• Blood pressure variations

  24-hour in-hospital day

Study Arms (2)

Type 2 Diabetes

Individuals with type 2 diabetes

Controls

Individuals without type 2 diabetes matched on age and body mass index

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary care clinic, Steno Diabetes Center Copenhagen out-patient clinic, community sample

You may qualify if:

• 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.

You may not qualify if:

• Body mass index (BMI) \<23 kg/m2
• Receipt of any investigational medicinal product within 3 months before screening in this trial.
• Inability to perform neuropsychological tests (e.g., visual impairment or auditory impairment, or language barrier).
• Participants with mental incapacity or language barriers precluding adequate understanding or co-operation or who, in the opinion of the investigator or their general practitioner, should not participate in the trial.
• Prior or contemporary use of any kind of hypnotica within 6 months, former p.n. use of melatonin is judged by the investigator.
• Nightshift-worker.
• Known dementia or any other major disorders that in the opinion of the investigator precludes compliance with the protocol, evaluation of the results or represent an unacceptable risk for the participant's safety.
• Diagnosed sleep disorders (e.g., sleep apnoea and narcolepsy).
• Significant history of alcoholism or drug/chemical abuse as per investigator's judgement.
• Severe hypoglycaemic event during the past 6 months requiring medical assistance.
• Diagnosed diabetic retinopathy.
• Severe renal insufficiency defined as estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73m2 or any kind of kidney disease that in the opinion of the investigator involves an unnecessary risk for the participants.
• Cardiac problems including any of the following:
• Classified as being in New York Heart Association (NYHA) class III or IV.
• Angina pectoris (chest pain) within the last 6 months.

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• Glostrup University Hospital, Copenhagen: collaborator
• University Hospital Bispebjerg and Frederiksberg: collaborator

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, plasma, serum

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Jørgen Rungby, MD, DMSc

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helena Z Wodschow, MD

CONTACT

+45 30313426; helena.zander.wodschow.03@regionh.dk

Jørgen Rungby, MD, DMSc

CONTACT

+45 21686620; joergen.rungby@regionh.dk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 6, 2024
• Study Start: February 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: November 7, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)