NCT03802253

Brief Summary

We evaluated the effects of Time-Restricted Eating (TRE) regimen on Impaired Glucose Regulation (IGR) in comparison with overweight/obese patients receiving standard of care over 12 months.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
May 2020Jun 2026

First Submitted

Initial submission to the registry

January 8, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 4, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

5.3 years

First QC Date

January 8, 2019

Last Update Submit

April 8, 2026

Conditions

Impaired Glucose RegulationOverweight/ObeseTime-restricted Eating

Outcome Measures

Primary Outcomes (1)

  • Incidence of regression to normoglycaemia among the studied population

    12 months

Secondary Outcomes (22)

  • Incidence of impaired glucose regulation progressing to diabetes

    12 months

  • Changes in body weight (Kilograms)

    3 months, 6 months and 12 months

  • Changes in waist circumference (cm)

    3 months, 6 months and 12 months

  • Change in body mass index (kg/m2)

    3 months, 6 months and 12 months

  • Changes in systolic pressure (mmHg)

    3 months, 6 months and 12 months

  • +17 more secondary outcomes

Study Arms (2)

TRE

EXPERIMENTAL

Participants in this group will focus on time restricted eating (TRE) in addition to daily calorie restriction.

Behavioral: Time Restricted eating(TRE)

RCD

ACTIVE COMPARATOR

Participants in this group will focus on standard care with daily reduced calorie diet (RCD)

Behavioral: Reduced Calorie Diet (RCD)

Interventions

Time Restricted eating(TRE)BEHAVIORAL

Participants will receive a diet of 1200-1500kcal/d and be instructed to eat only during a window of 8 hours (Finishing the last meal before 4pm) in the first 6 months. 6 months later, Participants will receive a diet of 1200-1500kcal/d without a restriction of eating time.

TRE
Reduced Calorie Diet (RCD)BEHAVIORAL

Participants will receive a diet of 1200-1500kcal/d and keep their usual eating pattern.

RCD

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged ≥ 18 year
  • Diagnosis of impaired glucose regulation (i.e. FG between 5.7-6.9mmol/L) +/- impaired glucose tolerance (i.e. 2-hour postprandial PG between 7.8-11.1mmol/L) confirmed by latest OGTT results within 3 months prior to recruitment
  • Body mass index (BMI)of 23.0 to 45.0 kg/m2;

You may not qualify if:

  • Confirmed diagnosis of DM or on hypoglycaemic treatment
  • Women who are pregnant or breast-feeding at recruitment
  • Patients taking glucocorticoid at recruitment
  • Active and uncontrolled thyroid diseases (including subjects on thyroid replacement therapy or anti-thyroid drugs) or active endocrine diseases such as Cushing's syndrome or Acromegaly at recruitment
  • Serious liver dysfunction or chronic kidney disease (AST or ALT \> 3 times the upper limit of normal, or eGFR\<30 ml/min/1.73 m2);
  • History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
  • Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
  • Currently participating in weight loss programs or weight change in the past 3 months (\> 5% current body weight) ;
  • Patients who cannot be followed for 24 months (due to a health situation or migration);
  • Patients who are unwilling or unable to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated hospital of Xiamen university

Xiamen, Fujian, 361003, China

Location

MeSH Terms

Conditions

OverweightObesityIntermittent Fasting

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFastingFeeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2019

First Posted

January 14, 2019

Study Start

May 4, 2020

Primary Completion

August 31, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

CN(1)