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New treatment option for Type 2 Diabetes
Official title Restricted Eating Time in the Treatment of Type 2 Diabetes
ClinicalTrials.gov ID: NCT06152588
What this study is testing
- What it's testing
- The overall aim of the present study is to investigate the effectiveness of implementing a 1-year time-restricted eating (TRE)-based intervention on glycaemic control, body weight and composition, cardiometabolic risk factors, and behaviour in individuals with overweight/obesity and type 2 diabetes (T2D).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age: ≥18 years
- Overweight or obesity (BMI ≥25 kg/m2)
- T2D with HbA1c\>53 mmol/mol
- Habitual eating window ≥12 h/day (incl. foods/snacks and energy-containing beverages)
You likely can't join if
- Bariatric surgery or planned bariatric surgery within study duration
- Use of fast acting insulin and combination insulin products
- Habitual CGM use
- A wish to adhere to Ramadan
- For women: current/planned pregnancy or lactation
- Alcohol or drug abuse (judged by investigator) or treatment with disulfiram
See the full eligibility criteria
- Age: ≥18 years
- Overweight or obesity (BMI ≥25 kg/m2)
- T2D with HbA1c\>53 mmol/mol
- Habitual eating window ≥12 h/day (incl. foods/snacks and energy-containing beverages)
- Bariatric surgery or planned bariatric surgery within study duration
- Use of fast acting insulin and combination insulin products
- Habitual CGM use
- A wish to adhere to Ramadan
- For women: current/planned pregnancy or lactation
- Alcohol or drug abuse (judged by investigator) or treatment with disulfiram
- Severe hypoglycaemia within last year (Severe hypoglycaemia, as defined by the American Diabetes Association (ADA), denotes severe cognitive impairment requiring external assistance for recovery)
- Inability to understand written and oral information in Danish
- Unable or unwilling to adhere to TRE; for instance, due to competing medical conditions.
- Medical condition which, based on investigators assessment, challenges participation including but not limited to severe heart, vascular or lung disease, cancer, chemotherapy, psychiatric, gastrointestinal, rheumatic...
- Concomitant participation in other intervention study
- Inability to perform neuropsychological tests (e.g., severe vision and hearing impairment that can-not be improved with aids such as glasses and hearing aids, or language barrier.) Exclusion criteria for the sub-study:
- Magnetic resonance imaging (MRI) contraindications based on the MR department's exclusion criteria including pacemaker or other implanted electronic devices, implanted metal objects not compatible to MRI scanning and...
- Participants who do not wish to be informed about accidental findings by MR.
The study team makes the final eligibility decision.
Where it's taking place
- Herlev, Denmark, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Herlev, Denmark, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.