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

NCT04923503 | Completed DMC

• 1 other identifier: RMD
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Fasting; Gut Hormone

Keywords

gut hormones; metabolic parameters; obesity; lean; diabetics; ramadan fasting

Outcome Measures

Primary Outcomes (4)

• change acylated ghrelin

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

  30 days

• change PYY

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

  30 days

• change GLP-1

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

  30 days

• change insulin

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

  30 days

Secondary Outcomes (1)

• change body weight

  30 days

Study Arms (3)

lean ramadan fasting

EXPERIMENTAL

conduct ramadan fasting for 30 days

Behavioral: diurnal fasting

obese ramadan fasting

EXPERIMENTAL

conduct ramadan fasting for 30 days

Behavioral: diurnal fasting

diabetics ramadan fasting

EXPERIMENTAL

conduct ramadan fasting for 30 days

Behavioral: diurnal fasting

Interventions

diurnal fasting BEHAVIORAL

subject conduct fasting in Ramadan for 30 days

Also known as: ramadan fasting

diabetics ramadan fasting; lean ramadan fasting; obese ramadan fasting

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Diponegoro: lead

Study Sites (1)

Etika Ratna Noer

Semarang, Central Java, 50275, Indonesia

Location

MeSH Terms

Conditions

Fasting; Obesity

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Etika R Noer

  Diponegoro University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: subject with random allocation Investigator do not know the group the analysator do not know the group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Nutrition, Medical Faculty

Model Details: three arm parallel group with 45 subjects: 1. fasting in lean group 2. fasting in obese group 3. fasting in diabetics group

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 11, 2021
• Study Start: March 1, 2021
• Primary Completion: April 12, 2021
• Study Completion: May 1, 2021
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: anytime
• Access Criteria: etikaratna@fk.undip.ac.id

Locations

ID (1)