Feasibility of Time-Restricted Eating in the Treatment of Type 2 Diabetes

NCT05375695 | Completed

• 1 other identifier: H-21041830
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of this pilot study is to examine feasibility of a 12-week 10-hour time-restricted eating intervention in individuals with overweight or obesity and type 2 diabetes. The results of the pilot study will inform recruitment, design and delivery of a future long-term time-restricted randomized controlled trial.

Conditions

Type 2 Diabetes

Keywords

time-restricted eating; type 2 diabetes; obesity; overweight; fasting; circadian rhythm

Outcome Measures

Primary Outcomes (4)

• Adherence (%)

  Self-reported adherence to a 10-hour eating window/day during a 8-week strict time-restricted eating period. % compliance = (number of days compliant/total days) \* 100%.

  Registered 1 day/week on random days per e-mail from baseline to week 8.

• Adherence (%)

  Self-reported adherence to a 10-hour eating window during a 4-week individually adjusted time-restricted eating period. % compliance = (number of days compliant/total days) \* 100%.

  Registered 1 day/week on random days per e-mail from week 8 to week 12.

• Participants' experiences, needs and barriers

  Analysis of conversations at visit 2 to assess participants' experiences, needs and barriers with a 8-week strict time-restricted eating period.

  8 weeks after baseline.

• Participants' experiences, needs and barriers

  Analysis of interviews at visit 3 to assess participants' experiences, needs and barriers with a 4-week individually adjusted time-restricted eating period, including to explore if intervention support components are acceptable, useful and sufficient for the participants.

  12 weeks after baseline.

Secondary Outcomes (41)

• Recruitment process and retention

  Up to 12 weeks.

• Evaluation of examination days

  Interviews at baseline and after 8 and 12 weeks.

• Fidelity

  Conversations at baseline and after 8 weeks.

• Body weight (kg)

  Measured at baseline and after 8 and 12 weeks

• Body mass index (kg/m^2)

  Measured at baseline and after 8 and 12 weeks.

Study Arms (1)

Time-restricted eating

EXPERIMENTAL

Time-restricted eating for 12 weeks (n=20).

Other: Time-restricted eating

Interventions

Time-restricted eating OTHER

The intervention consists of an 8-week strict time-restricted eating period, where participants follow the same 10-hour eating window (self-selected timing from 6 am to 8 pm) each day with minimal support to obtain lived experiences with challenges associated with time-restricted eating. Followed by an individually adjusted 4-week time-restricted eating period, including supporting components. Staff will help participants select a time-interval that fits into their daily life. Diet is ad libitum and with no further dietary restrictions. The time-restricted eating intervention is an addition to standard care.

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)
• Associated with the T2D clinic at Steno Diabetes Center Copenhagen (SDCC) or Hvidovre Hospital

You may not qualify if:

• Weight loss \>5kg last 3 months
• Bariatric surgery or planned bariatric surgery within study duration
• Use of fast acting insulin and combination insulin products
• Unable or unwilling to adhere to time-restricted eating; for instance, due to competing medical conditions.
• 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, denotes severe cognitive impairment requiring external assistance for recovery)
• Inability to understand written and oral information in Danish.
• Diagnosed with an eating disorder in the past 3 years
• 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

Sponsors & Collaborators

• Kristine Færch: lead
• Hvidovre University Hospital: collaborator
• University of Leeds: collaborator
• Salk Institute for Biological Studies: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

Location

Related Publications (1)

• Termannsen AD, Bjerre N, Hansen GS, Jalking L, Faerch K, Hempler NF, Quist JS, Varming A. Theory-based process evaluation of a non-randomised single-arm pilot study investigating time-restricted eating in the treatment of type 2 diabetes-the RESET2 pilot study. Pilot Feasibility Stud. 2025 Nov 6;11(1):135. doi: 10.1186/s40814-025-01715-4.

  PMID: 41199408 DERIVED

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

• Kristine Færch, PhD

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Research Leader, PhD

Study Record Dates

• First Submitted: March 27, 2022
• First Posted: May 17, 2022
• Study Start: April 1, 2022
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2022
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)