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

Launched by STENO DIABETES CENTER COPENHAGEN · Feb 5, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how people with type 2 diabetes (T2D) experience differences in their body’s natural rhythms compared to healthy individuals. Specifically, the study aims to understand how the timing of hormones like melatonin and cortisol may vary between those with T2D and those without. Researchers believe that these differences could affect various aspects of health, including metabolism, heart function, and mental performance.

To participate, you need to be between 50 and 75 years old and either have type 2 diabetes (diagnosed for at least three months) or be a healthy control without diabetes. Participants will keep a diary of their eating and sleeping habits for a month, wear a device that tracks activity and glucose levels for about two weeks, and spend a night at the research facility for further tests. This study is currently recruiting, and it's important to know that certain health conditions and treatments may exclude you from participating.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 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.
• Exclusion Criteria:
• • 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:
• • 1. Classified as being in New York Heart Association (NYHA) class III or IV.
• • 2. Angina pectoris (chest pain) within the last 6 months.
• • Inadequately treated blood pressure at screening defined as repeated resting blood pressure outside the rage 90-150 mmHg for systolic and 50-100 mmHg for diastolic blood pressure.
• • Known lung disease that in the opinion of the investigator represents an unacceptable risk for the participant's safety.
• • Active or recent (≤ 12 months) malignant disease is judged by the investigator.
• • For females only: Pregnancy, breast-feeding status, or intention of becoming pregnant during the trial.
• • For healthy matched controls: prediabetes defined as HbA1c between 42-47 mmol/mol