Determination of the Effect of Mango Leaf Extract on Metabolic Indices of Patients with Type 2 Diabetes including Fasting Blood Sugar, 2hpp, Lipid Profile, BMI
Design
This is a randomized Double-blinded clinical trial with two parallel groups in Phase 3. In this study 40 patients with type 2 diabetes referring to specialized clinic and Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
This study will be carried out in the specialized clinic of Kerman University of Medical Sciences. In this study, patients were randomly divided into drug and placebo groups using randomization software. Patients and drug providers are not aware of the type of capsules they receive. At the beginning and at the end of the study, 10 ml of fasting venous blood was taken from all patients. Anthropometric characteristics data of patients will be recorded. At the beginning and end of the study, fasting glucose, 2hpp, fasting insulin, and lipid profiles will be determined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: type 1 diabetes based on World Health Organization Guidelines from at least 6 months ago; taking oral hypoglycemic drugs; age 25-60 years old.
Exclusion criteria: changes in blood glucose drugs from 2 months prior to study; insulin use; smoking; pregnancy; use of herbal medications; lactation; digestive and liver problems; hormonal problems such as thyroid dysfunction; heart problems; consumption drugs that interfere with blood sugar and lipid levels; such as non-steroidal anti-inflammatory drugs.
Intervention groups
Patients with age between 25 to 60 years old with type 2 diabetes receive 500 mg capsules containing mango leaf extract twice daily (before lunch and before dinner) for 45 days.
Main outcome variables
FBS; 2HPP; fasting insulin; lipid profiles; BMI
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180923041093N2
Registration date:2019-10-12, 1398/07/20
Registration timing:prospective
Last update:2019-10-12, 1398/07/20
Update count:0
Registration date
2019-10-12, 1398/07/20
Registrant information
Name
Fatemeh sadat Hasheminasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5333 8547
Email address
hashemifa67@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-21, 1398/08/30
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Mangifera indica extract supplement on metabolic status in type 2 diabetic patients
Public title
Effect of mango leaf on diabetes on lipid profiles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 1 Diabetes According to the World Health Organization's online guide from 6 months ago
Taking blood sugar lowering drugs
Exclusion criteria:
Changes in diabetes medications from 2 months before the study
Insulin consumption
Smoking
Pregnancy
Use of herbal medications
Lactation
Gastrointestinal and liver problems
Hormonal problems such as thyroid dysfunction
Cardiac problems
Medications that interfere with blood sugar and lipid levels such as non-inflammatory drugs Steroid
Age
From 25 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
By random allocation software
Blinding (investigator's opinion)
Double blinded
Blinding description
Drug coding will be done by a third party and during the study, not everyone, including physicians, patients, and those responsible for drug delivery will be aware of the type of drug used and the placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethic committee of Kerman University of Medical Sciences
Street address
Beginning of Ibn Sina Street, Beginning of Jihad Blvd., Somayeh Road (Tahmasebabad), Kerman
City
Kerman
Province
Kerman
Postal code
584-76175
Approval date
2019-04-21, 1398/02/01
Ethics committee reference number
IR.KMU.REC.1398.085
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Fasting blood sugar
Timepoint
Baseline and 45 days after the intervention
Method of measurement
Fasting serum Glucose concentration in mg/dl by kit
2
Description
2 hours post prandial
Timepoint
Baseline and 45 days after the intervention
Method of measurement
Fasting serum Glucose concentration in mg/dl by kit
3
Description
Fasting Insulin
Timepoint
Baseline and 45 days after the intervention
Method of measurement
Fasting serum Insulin concentration in µU/ml by kit
4
Description
Serum Teriglycerid
Timepoint
Baseline and 45 days after the intervention
Method of measurement
Fasting serum Teriglycerid concentration in mg/dl by kit
5
Description
Serum cholestrol
Timepoint
Baseline and 45 days after the intervention
Method of measurement
Fasting Serum cholestrol concentration in mg/dl by kit
6
Description
LDL Cholestrol
Timepoint
Baseline and 45 days after the intervention
Method of measurement
Fasting Serum HDL Cholestrol concentration in mg/dl, calculating by Friedewald formula
7
Description
HDL Cholestrol
Timepoint
Baseline and 45 days after the intervention
Method of measurement
Fasting Serum HDL Cholestrol concentration in mg/dl by kit
8
Description
Body mass index
Timepoint
Baseline and 45 days after the intervention
Method of measurement
Weight to square height ratio
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mango leaf extract 500 mg, twice daily, for 45 days
Category
Treatment - Other
2
Description
Control group: Placebo 500 mg twice daily for 45 days