Restricted Eating Time in the Treatment of Type 2 Diabetes

NCT06152588 | Recruiting

• 1 other identifier: H-23035125
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Type 2 Diabetes

Keywords

Time-restricted eating; Type 2 Diabetes; Obesity; Overweight; Fasting; Circadian rhythm

Outcome Measures

Primary Outcomes (2)

• Change in HbA1c (mmol/mol)

  Assessed from blood samples in fasted state.

  Change from baseline to 3-months of intervention (strict TRE)

• Change in HbA1c (mmol/mol)

  Assessed from blood samples in fasted state.

  Change from baseline to the end of the intervention (12 months)

Secondary Outcomes (4)

• Body weight (kg)

  Change from baseline to end of the intervention (12 months). Measured at baseline, 3 months, 12 months

• Fat mass (kg)

  Change from baseline to end of the intervention (12 months). Measured at baseline, 3 months, 12 months

• Time in range (% 3.9-10.0 mmol/l)

  Change from baseline to end of the intervention (12 months). Measured at baseline, 3 months, 12 months

• Use of antidiabetic medication

  Change from baseline to end of the intervention (12 months). Assessed at baseline, 3 months, 12 months.

Other Outcomes (77)

• Body weight (kg)

  Change from baseline to 3 months

• Height (m)

  Measured only at screening

• Body mass index (kg/m^2)

  Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

Study Arms (2)

Time-restricted eating

EXPERIMENTAL

TRE group for 1 year: The intervention consists of a 3-month (12 weeks) strict TRE period, where participants follow the same eating window each day with minimal support, followed by a 9-month (40 weeks) period of individually adjusted TRE according to their experiences.

Other: Time restricted eating

Control

NO INTERVENTION

Control group for 1 year: Participants will be instructed to continue their habitual lifestyle during the study and they will follow standard care with regular visits at the SDCC clinic 3-4 times/year.

Interventions

Time restricted eating OTHER

3 months (12 weeks) strict TRE intervention: Participants will be instructed to reduce their eating window by minimum 3 hours compared to habitual eating, with an eating window below 10 hours. The timing of the eating window is self-selected but should be placed between 6 am and 8 pm. Diet during the eating window is ad libitum with no further dietary restrictions. 9 months (40 weeks) individually adjusted TRE intervention: An individual plan will be made based on participants' experiences during the strict TRE. Different choices of individual adjustment and support will be provided, including 1) eating window adjustments and the possibility of 'days off', 2) provision of a list of allowed calorie and caffeine free beverages that can be consumed outside the window, 3) continued opportunity to participate in peer-support group meetings, 4) extra phone calls with a project worker to discuss challenges or strategies to continue with TRE etc., and 5) further involvement of relatives.

Time-restricted eating

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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
• 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, or endocrine diseases etc.
• 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.)
• Participants who do not wish to be informed about accidental findings by MR.

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• University of Leeds: collaborator
• Salk Institute for Biological Studies: collaborator
• University of Copenhagen: collaborator
• Glostrup University Hospital, Copenhagen: collaborator

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, Denmark, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Intermittent Fasting; Obesity; Overweight; Fasting

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Feeding Behavior; Behavior; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonas S Quist, PhD

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonas S Quist, PhD

CONTACT

+45 26176064; jonas.salling.quist@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 30, 2023
• Study Start: March 21, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)