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

• Sponsor: Universitas Diponegoro (Other)
• Overall Status: Completed
• CT.gov ID: NCT04923503
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 3
• Actual Duration (Months): 2
• Patients Per Site Per Month: 22.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Fasting; Gut Hormone	Behavioral: diurnal fasting	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: three arm parallel group with 45 subjects: fasting in lean group fasting in obese group fasting in diabetics groupthree arm parallel group with 45 subjects: fasting in lean group fasting in obese group fasting in diabetics group
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: subject with random allocation Investigator do not know the group the analysator do not know the group
• Primary Purpose: Treatment
• Official Title: Department of Nutrition Science, Medical Faculty, Universitas Diponegoro, Semarang, Indonesia
• Actual Study Start Date: Mar 1, 2021
• Actual Primary Completion Date: Apr 12, 2021
• Actual Study Completion Date: May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: lean ramadan fasting conduct ramadan fasting for 30 days	Behavioral: diurnal fasting; subject conduct fasting in Ramadan for 30 days; Other Names: ramadan fasting
Experimental: obese ramadan fasting conduct ramadan fasting for 30 days	Behavioral: diurnal fasting; subject conduct fasting in Ramadan for 30 days; Other Names: ramadan fasting
Experimental: diabetics ramadan fasting conduct ramadan fasting for 30 days	Behavioral: diurnal fasting; subject conduct fasting in Ramadan for 30 days; Other Names: ramadan fasting

Outcome Measures

Primary Outcome Measures

1. change acylated ghrelin [30 days]

   Change from Baseline acyl ghrelin at 30 days taken in the lab from venous blood specimen

2. change PYY [30 days]

   Change from Baseline PYY at 30 days taken in the lab from venous blood specimen

3. change GLP-1 [30 days]

   Change from Baseline GLP-1 at 30 days taken in the lab from venous blood specimen

4. change insulin [30 days]

   Change from Baseline Insulin at 30 days taken in the lab from venous blood specimen

Secondary Outcome Measures

1. change body weight [30 days]

   Change from Baseline body weight at 30 days

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Etika Ratna Noer	Semarang	Central Java	Indonesia	50275

Sponsors and Collaborators

• Universitas Diponegoro

Investigators

• Principal Investigator: Etika R Noer, Diponegoro University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Etika Ratna Noer, Department of Nutrition, Medical Faculty, Universitas Diponegoro
• ClinicalTrials.gov Identifier: NCT04923503
• Other Study ID Numbers: RMD
• First Posted: Jun 11, 2021
• Last Update Posted: Jun 29, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Etika Ratna Noer, Department of Nutrition, Medical Faculty, Universitas Diponegoro: gut hormones; metabolic parameters; obesity; lean; diabetics; ramadan fasting

Study Results

No Results Posted as of Jun 29, 2021