Clinical trial NCT04923503: Diurnal Ramadan Fasting on Appetite Hormone and Metabolic Profile Among Lean, Obesity, Diabetics
Official title: Department of Nutrition Science, Medical Faculty, Universitas Diponegoro, Semarang, Indonesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasting
Gut Hormone
Keywords: gut hormones
metabolic parameters
obesity
lean
diabetics
ramadan fasting
Lead sponsor: Universitas Diponegoro
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 45
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: three arm parallel group with 45 subjects:

1. fasting in lean group
2. fasting in obese group
3. fasting in diabetics group
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: change acylated ghrelin
timeFrame: 30 days
measure: change PYY
timeFrame: 30 days
measure: change GLP-1
timeFrame: 30 days
measure: change insulin
timeFrame: 30 days
Secondary outcomes:
measure: change body weight
timeFrame: 30 days
Other outcomes:
Locations:
city: Semarang
country: Indonesia
facility: Etika Ratna Noer
state: Central Java
Study officials:
affiliation: Diponegoro University
name: Etika R Noer
role: PRINCIPAL_INVESTIGATOR
References: