Diurnal Ramadan Fasting on Appetite Hormone and Metabolic Profile Among Lean, Obesity, Diabetics

Not Applicable

Completed

• Conditions: Fasting; Gut Hormone
• Interventions: Behavioral: diurnal fasting

• Registration Number: NCT04923503
• Lead Sponsor: Universitas Diponegoro

Brief Summary

Diabetes Mellitus individuals are known to have dietary rules, namely regulating the amount, type and time of eating. Ramadan fasting seems to be beneficial for people who want to reduce their weight, but it is not easy for diabetic patients. Because of its distinctive features, Ramadhan induces changes in eating habits, calorie consumption, sleeping patterns, and daily physical activity, which may contribute to changes in hunger-satiety responses and glicemic control. Examining changes in gut hormones during Ramadan fasting may reveal whether this observance could change glucose metabolism in diabetics without triggering the undesirable effect of gluconeogenesis. The proportions of fat, protein, and carbohydrate in meals vary between outside and within Ramadan. Alterations in timing and composition meal during Ramadan lead to reduced food intake may affect gut hormones and metabolic responses. The aim of this study to determine whether the effect of Ramadan fasting differed in people with DM patients, pre-DM and healthy individuals, with respect to gut hormones, body composition, metabolic parameters, and glycemic control

Detailed Description

The experimental study was performed during and after Ramadan fasting in 2021 (April to May) in Semarang, Indonesia. The present study was performed using the quasy-experimental method by pre-post measurement of three experimental groups (diabetics, Obese and healthy subjects) selected using the purposive sampling methods

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2021-04-12
• Study Completion: 2021-05-01
• Status Verified: 2021-06
• Study First Submitted: 2021-06-06
• Study First Submitted QC: 2021-06-06
• Study First Posted: 2021-06-11
• Last Update Submitted: 2021-06-26
• Last Update Posted: 2021-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Diabetics subjects: glucose fasting plasma > 200 mg/dL, with aged 35-60 years and body mass index above 25 kg/m;
• Obese subjects: body mass index above 25 kg/m2 with aged 35-60 years and waist circumference for men >90 cm, for women > 80 cm
• Lean subjects: body mass index below 23.5 kg/m2 with aged 35-60 years and waist circumference for men <90 cm, for women < 80 cm

Exclusion Criteria

• experienced weight loss more than 10% from the actual weight in the last three months
• consumed medicine or supplement for weight loss diet, •. had the history of evidence of clinical depression, cognitive disorders, heart disease, cancer, liver or renal disease, chronic pulmonary disease, uncontrolled hypertension, physical disability, or other contraindications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
diabetics ramadan fasting	diurnal fasting	conduct ramadan fasting for 30 days
obese ramadan fasting	diurnal fasting	conduct ramadan fasting for 30 days
lean ramadan fasting	diurnal fasting	conduct ramadan fasting for 30 days

Primary Outcome Measures

Name	Time	Method
change PYY	30 days	Change from Baseline PYY at 30 days taken in the lab from venous blood specimen
change insulin	30 days	Change from Baseline Insulin at 30 days taken in the lab from venous blood specimen
change acylated ghrelin	30 days	Change from Baseline acyl ghrelin at 30 days taken in the lab from venous blood specimen
change GLP-1	30 days	Change from Baseline GLP-1 at 30 days taken in the lab from venous blood specimen

Secondary Outcome Measures

Name	Time	Method
change body weight	30 days	Change from Baseline body weight at 30 days

Trial Locations

Locations (1)

Etika Ratna Noer; 🇮🇩 Semarang, Central Java, Indonesia