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Efficacy of time restricted eating and economic behavioral intervention in reducing fasting plasma glucose, HbA1c, and cardiometabolic risk factors compared to time restricted eating alone or usual care in patients with prediabetes: A randomized controlled trial

Phase 3
Recruiting
Conditions
Impaired fasting glucose Time restricted eating
impaired glucose tolerence
Registration Number
TCTR20210520002
Lead Sponsor
ational Research Council of Thailand (NRCT)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
114
Inclusion Criteria

impaired fasting glucose (100-125 mg/dL) or abnormal HbA1c (5.7-6.49%)
age 18-65 years
BMI more than 25 kg/m2

Exclusion Criteria

1. Currently on ketogenic diet or vegeterian diet
2. Currently on TRE
3. Shift work
4. Weight change more than 5 kg in 3 months
5. Having medication which has to be taken at early morning or at night
6. Smoking
7. Breast feeding
8. Psychological disorder excluding depression
9. Having medications which affect weight and blood sugar
10. History of bariatric surgery
11. Impaired nutrient absorption

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Fasting blood sugar 4,8,12 weeks hexokinase glucose-6 phosphate dehydrogenase and turbid metric inhibition immunoassay ,HbA1C 4,8,12 weeks hexokinase glucose-6 phosphate dehydrogenase and turbid metric inhibition immunoassay
Secondary Outcome Measures
NameTimeMethod
Body weight 4,8,12 weeks weight measurement (kg) ,Systolic blood pressure 4,8,12 weeks mmHg,Diastolic blood pressure 4,8,12 weeks mmHg,Fasting insulin 4,8,12 weeks mIU/mL,serum triglyceride 4,8,12 weeks mg/dL ,Total cholesterol 4,8,12 weeks mg/dL,LDL-C 4,8,12 weeks mg/dL,HDL-C 4,8,12 weeks mg/dL ,high sensitivity C-reactive protein 4,8,12 weeks mg/dL
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