The Evaluate of Low Acidic Load Diet on Blood Pressure, Lipid Profiles, Blood Glucose Control Indices and Insulin Resistance in Patients with Type 2 Diabetes
The Aim of This study is Evaluating of Low Acidic Load Diet on Blood Pressure, Lipid Profiles, Blood Glucose Control Indices and Insulin
Resistance in Patients with Type 2 Diabetes
Design
80 type 2 diabetic patients will be randomly divided into two groups of intervention with low acidic diet (n = 40 Individuals) and control group with normal diet (n = 40 Individuals)
Settings and conduct
The Study is being conducted in the Diabetic Clinic. Both Intervention and Control Groups are prescribed Diet for Patients with Type 2 Diabetes. Calorie Calculation is based on the Mifflin Formula. in this Formula is used of Current Weight for patients with Normal Body Mass Index and Adjusted Weight for Obese or Overweight Patients. In Obese and Overweight Patients, 500 k cal of the Calculated Energy is Reduced.The Food Exchange List varies for each Group. In Food Exchange list of the Intervention Group, Foods are ranked according to the Acidic load of the Lowest Acidic Load to High Acid Load , Respectively and High-Acid Foods have been eliminated. Food Exchange List of Control Group is the usual Food Exchange List for Diabetics. In the Intervention Group's Daily Menu, there are two Constant Snacks of very low Acidic Foods.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
People Over 20 and Under 65 Years Old
People with Body Mass Index above 18.5
Exclusion criteria:
Cancer,
Cushing's Syndrome,
Diabetic Nephropathy,
Respiratory Diseases such as: Chronic Obstructive Pulmonary Disease,
pregnant or breast-feeding,
having Enteral or Parenteral feeding,
Take Glucocorticosteroids and Insulin
Intervention groups
Diabetic Patients are divided into Intervention and Control Groups, The Intervention Group Received a Low Acidic Diet for 12 Weeks and the Diabetic Control Group Received the Usual Diet.
Main outcome variables
Fasting Blood Sugar Concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130903014551N5
Registration date:2020-03-22, 1399/01/03
Registration timing:prospective
Last update:2020-03-22, 1399/01/03
Update count:0
Registration date
2020-03-22, 1399/01/03
Registrant information
Name
Mohammad Hossein Rouhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3183
Email address
s_m_rouhani2003@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-19, 1399/01/31
Expected recruitment end date
2020-04-25, 1399/02/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Evaluate of Low Acidic Load Diet on Blood Pressure, Lipid Profiles, Blood Glucose Control Indices and Insulin Resistance in Patients with Type 2 Diabetes
Public title
The Evaluate of Alkalin Diet on Blood Pressure, Blood Lipid, Blood Glucose in Patients with Type 2 Diabetes
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
People with Type 2 Diabetes Over 20 and Under 65 Years Old
People with Type 2 Diabetes with Body Mass Index above 18.5
Exclusion criteria:
cancer
Cushing's Syndrome
Taking Glucocorticoids
Diabetic Nephropathy
Respiratory Diseases such as: Chronic Obstructive Pulmonary Disease
Pregnancy and Lactation
Enetral and Parenteral Feeding
Use Insulin
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Our Randomization Method is Simple and Randomization Unit is Individual
We first give each person a code, then enter the code into the spss software Finally, the process of random selection of software runs.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
--
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of isfahan university of medical sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Azadi Square, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-02-04, 1398/11/15
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.664
Health conditions studied
1
Description of health condition studied
Type 2 Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Fasting Blood Sugar Concentration
Timepoint
Measurement of Fasting Blood Sugar Concentration at Baseline and 12 Weeks Later
Method of measurement
Biochemical Testing to Measure Fasting Blood Sugar
Secondary outcomes
1
Description
Serum hemoglobin A1C Concentration
Timepoint
Serum Concentration of Hemoglobin A1C Measurement at Baseline and 12 Weeks Later
Method of measurement
Biochemistry Test to Measure Serum Concentration of Hemoglobin A1C
2
Description
Serum Concentration of Insulin
Timepoint
Measurement of Serum Insulin Concentration at Baseline and 12 Weeks Later
Method of measurement
Biochemistry Test to Measure Serum Concentration of Insulin
Measurement of Insulin Sensitivity Index at Baseline and 12 Weeks Later
Method of measurement
Using the Quantitative Insulin Sensitivity Check Index(QUICKI)
4
Description
Blood Pressure
Timepoint
Measurement of Blood Pressure at Baseline and 12 Weeks Later
Method of measurement
Using Mercury Barometer
5
Description
Serum Concentration of Lipid Profile (Total Cholesterol, Low Density Lipoprotein, High Density Lipoprotein, Triglyceride)
Timepoint
Measurement of Serum Concentration of Lipid Profile (Total Cholesterol, Low Density Lipoprotein, High Density Lipoprotein, Triglyceride) at Baseline and 12 Weeks Later
Method of measurement
Biochemistry Test to Measure Serum Concentration of Lipid Profile
6
Description
Insulin Resistance Index (Homeostasis Model Assessment (HOMA))
Timepoint
Measurement of Insulin Resistance Index at Baseline and 12 Weeks Later
Method of measurement
Using the Hemostasis Model Assessment Formula (HOMA)
Intervention groups
1
Description
Intervention group: This Group is given a Diabetic Diet for 12 weeks That has been used Low-Acid Foods and has been Eliminated of High-Acid Foods in Their Diet
Category
Other
2
Description
Control group: This Group is Given a Normal Diabetic Diet.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Seyed Mohammad Hossein Rouhani
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Fax
Email
sm_rouhani@nutr.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard
Street address
Deputy of Research & Technology of Esfahan University of Medical Sciences, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Fax
+98 31 3668 7898
Email
sh_haghjoo@med.mui.ac.ir
Web page address
http://research.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Seyed Mohammad Hossein Rouhani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Esfahan University of Medical Sciences, Hezar Jarib Street, Esfahan, Iran
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Email
sm_rouhani@nutr.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Seyed Mohammad Hossein Rouhani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Email
sm_rouhani@nutr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Seyed Mohammad Hossein Rouhani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3183
Email
sm_rouhani@nutr.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available