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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03792282
Other study ID # KYH2018-017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 7, 2019
Est. completion date July 31, 2023

Study information

Verified date August 2023
Source The First Affiliated Hospital of Xiamen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aims of the present study is to examine whether Time-Restricted Feeding (TRF) is a safe and effective regimen to improve insulin resistance and decrease body weight in overweight/obese Polycystic ovary syndrome (PCOS) patients over 16 weeks compared to reduced energy restriction.


Description:

Intermittent fasting regimens involve periods fasting followed by periods of eating freely. Time-Restricted Feeding (TRF) is a new form of intermittent fasting and involves shortening the eating window to 4-10 h/day. TRF is a safe lifestyle intervention for weight loss in adults with obesity. Accumulating evidence suggests that TRF is an effective means of decreasing body weight and improving insulin resistance but did not have any negative impact on eating disorder symptoms, body image perception, or eating behaviors. Polycystic ovary syndrome (PCOS) is the most common endocrine condition in productive-aged women. About 60-70 % of women with PCOS are obese or overweight, and obesity is associated with insulin resistance. Since many women with PCOS seem to have insulin resistance, compensatory hyperinsulinemia is thought to contribute to hyperandrogenism by direct stimulation of ovarian production of androgens and by inhibition of liver synthesis of SHGB. It is important to ameliorate insulin resistance in PCOS patients.The aims of the present study is to examine whether TRF is a safe and effective regimen to improve insulin resistance and decrease body weight in overweight/obese PCOS patients.


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date July 31, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Age = 18 years - BMI=24kg/m2 - Polycystic ovary syndrome has been diagnosed Exclusion Criteria: - 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; - The body weight fluctuated more than 5% in recent 3 months. - Liver and kidney dysfunction: renal impairment, creatinine clearance rate < 30 mL/min/1.73 m2, transaminase increased, more than three times higher than the normal limit; - History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months; - History of thyroid diseases; - Having been in pregnancy. - Researchers believe that there are any factors that affect assessing subjects' participation in trial. - History of malignant tumors; - History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity; - Currently participating in weight loss programs or weight change in the past 3 months (> 5% current body weight) - Patients who cannot be followed for 16 months (due to a health situation or migration) - Patients who are unwilling or unable to give informed consent.

Study Design


Intervention

Behavioral:
Time Restricted Feeding
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).
Usual care
Participants receive a general lifestyle counseling.

Locations

Country Name City State
China The first afilliated hospital of Xiamen university Xiamen Fujian

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in body weight (Kilograms) Changes in body weight (Kilograms) Baseline and 16 weeks
Primary Change in insulin resistance Insulin resistance will be assessed by HOMA-IR Baseline and 16 weeks
Secondary Changes in waist circumference (cm) Baseline and 16 weeks
Secondary Changes in abdominal circumference (cm) Baseline and 16 weeks
Secondary Changes in systolic pressure(SBP) Baseline and 16 weeks
Secondary Changes in diastolic pressure (DBP) Baseline and 16 weeks
Secondary Change in ß cell function ß cell function will be assessed by HOMA-ß Baseline and 16 weeks
Secondary Change in LDL-c level Baseline and 16 weeks
Secondary Change in TG level Baseline and 16 weeks
Secondary Change in CHO level Baseline and 16 weeks
Secondary Change in liver fiber liver fiber will be assessed by Controlled attenuation parameter (CAP) evaluated with transient elastography (FibroScan®) Fibroscan Baseline and 16 weeks
Secondary Changes in systemic Inflammatory biomarkers Inflammatory biomarkers (TNFa,CRP and Interleukin-6) are measured by ELISA (enzyme-linked immunosorbent assay). Baseline and 16 weeks
Secondary Changes in Oxidative stress markers Oxidative stress markers include the circulating levels of Catalase,Glutathione Peroxidase, and Malondialdehyde. Baseline and 16 weeks
Secondary Change in depressive symptoms as assessed by Patient Health Questionnaire-9 Baseline and 16 weeks
Secondary Change in quality of life measured by the 12-item Short-Form Health Survey Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12) Baseline and 16 weeks
Secondary Changes in time to return to normal menstrual cycle Changes in time to return to normal menstrual cycle Baseline and 16 weeks
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