Examining daily metabolic and behavioral patterns in people with and without Type 2 Diabetes

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

This study is trying to see how daily eating and sleeping patterns differ between people with Type 2 Diabetes and those without, to understand how it affects their hormones and behavior.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 50 Years to 75 Years
• Sex: All
• Sponsor: Steno Diabetes Center Copenhagen (Academic / other)
• Locations: 1 site (Herlev)
• Trial ID: NCT06243172 on ClinicalTrials.gov

What this trial studies

This observational study aims to characterize hormonal differences in circadian rhythms between individuals with Type 2 Diabetes (T2D) and healthy controls. Participants will maintain a diary of their eating and sleeping habits for 30 days, wear an actigraphy and continuous glucose monitor for 10-14 days, and undergo overnight monitoring at the research facility, including blood sampling and sleep studies. The study hypothesizes that T2D individuals exhibit misaligned circadian rhythms, which may impact their hormonal fluctuations, behavior, and cognitive functions.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 50-75 with a clinical diagnosis of Type 2 Diabetes for at least 5 years and healthy age and weight-matched controls.

Not a fit: Patients with a body mass index below 23 kg/m2 or those unable to perform neuropsychological tests may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into how circadian misalignment affects individuals with Type 2 Diabetes, potentially leading to improved management strategies.

How similar studies have performed: While studies have explored circadian rhythms in various contexts, this specific approach comparing T2D patients with matched controls is relatively novel.

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

Where this trial is running

Herlev

• Steno Diabetes Center Copenhagen — Herlev, Denmark (Recruiting)

Study contacts

• Principal investigator: Jørgen Rungby, MD, DMSc — Steno Diabetes Center Copenhagen
• Study coordinator: Helena Z Wodschow, MD

Conditions Type 2 Diabetes; Circadian Rhythm; Cognition; Sleep