The Effect of Orlistat in Treatment of Patients with Diabetes

The Effectivness of Orlistat on Symptoms of Diabetic Patients with Overweight and Constipation; A Double-Blinded Randomized Controlled Clinical Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191106045356N15

Enrollment

Registered

2023-01-24

Start date

2023-02-20

Completion date

Unknown

Last updated

2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes. Diabetes mellitus due to underlying condition

Interventions

Intervention 1: Intervention group: taking orlistat capsules (Abureihan co., IRAN) orally with a daily dosage of 120 mg with lunch for three months. Intervention 2: Control group: taking capsules of t

Eligibility

Sex/Gender

All

Age

35 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes who are suffered from constipation aged between 30 to 60 years old BMI equal or more than 29

Exclusion criteria

Exclusion criteria: Diabetic patients with kidney dissease and GFR less than 60 Diabetic patients with diabetic gastroparesis with bloating and feeling heaviness in the chest Patients with a history of allergic reactions to Orlistat Not taking medicine for more than three consecutive days Drug intolerance

Design outcomes

Primary

Measure	Time frame
Fasting blood sugar. Timepoint: At baseline, 45 days and 3 months after the intervention. Method of measurement: Glucometer.;Glucose tolerance test. Timepoint: At baseline, 45 days and 3 months after the intervention. Method of measurement: Consumption of 75 grams of glucose in the fasting state and measuring blood sugar with a glucometer after 2 hours.;HbA1c. Timepoint: At baseline, 45 days and 3 months after the intervention. Method of measurement: By the kit.;Body mass index. Timepoint: At baseline, 45 days and 3 months after the intervention. Method of measurement: The result of dividing the weight by the square of the patient's height.;Number of bowel movements per day. Timepoint: At baseline, 45 days and 3 months after the intervention. Method of measurement: questionnaire.;History of taking laxatives. Timepoint: At baseline, 45 days and 3 months after the intervention. Method of measurement: questionnaire.;The level of patient satisfaction with defecation and digestive disorders. Timepoint: At baseline, 45 days and 3 months after the intervention. Method of measurement: questionnaire.	—

Measure

Time frame

Fasting blood sugar. Timepoint: At baseline, 45 days and 3 months after the intervention. Method of measurement: Glucometer.;Glucose tolerance test. Timepoint: At baseline, 45 days and 3 months after the intervention. Method of measurement: Consumption of 75 grams of glucose in the fasting state and measuring blood sugar with a glucometer after 2 hours.;HbA1c. Timepoint: At baseline, 45 days and 3 months after the intervention. Method of measurement: By the kit.;Body mass index. Timepoint: At baseline, 45 days and 3 months after the intervention. Method of measurement: The result of dividing the weight by the square of the patient's height.;Number of bowel movements per day. Timepoint: At baseline, 45 days and 3 months after the intervention. Method of measurement: questionnaire.;History of taking laxatives. Timepoint: At baseline, 45 days and 3 months after the intervention. Method of measurement: questionnaire.;The level of patient satisfaction with defecation and digestive disorders. Timepoint: At baseline, 45 days and 3 months after the intervention. Method of measurement: questionnaire.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Naseri

Yazd University of Medical Sciences

neginaseri@yahoo.com+98 912 041 5841

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026