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Comparison of the effect of intensive lifestyle intervention including two diets, calorie-carbohydrate restricted diet and the time restricted feeding on glycemic biomarkers, eating disorders, and appetite, in overweight and obese type 2 diabetic patients: a randomized controlled trial study

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History
# Registration date Revision Id
3 2026-05-07, 1405/02/17 377749
2 2024-10-31, 1403/08/10 323624
1 2023-09-24, 1402/07/02 279760
Changes made to previous revision

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  • Primary outcomes

    #1
    Glycosylated hemoglobin
    Appetite self-report score
    هموگلوبین گلیکوزیله
    امتیاز خودگزارش دهی اشتها
    Blood test
    Visual Analogue Scale
    آزمایش خون
    مقیاس آنالوگ بصری
    #2
    Fasting blood sugar
    Eating Disorder Examination Score
    قندخون ناشتا
    امتیاز آزمون اختلال خوردن
    Blood test
    Eating Disorder Examination Questionnaire (EDEQ)
    نمونه خون
    پرسشنامه آزمون اختلال خوردن
    #3
    Insulin
    empty
    انسولین
    empty
    First, 3 months and 6 months after the start of the study
    empty
    ابتدا، 3 ماه و 6 ماه پس از شروع
    empty
    Blood test
    empty
    نمونه خون
    empty
    #4
    Insulin resistance index
    empty
    شاخص مقاومت به انسولین
    empty
    First, 3 months and 6 months after the start of the study
    empty
    ابتدا، 3 ماه و 6 ماه پس از شروع
    empty
    Formula
    empty
    فرمول
    empty
    #5
    Appetite self-report score
    empty
    امتیاز خودگزارش دهی اشتها
    empty
    First, 3 months and 6 months after the start of the study
    empty
    ابتدا، 3 ماه و 6 ماه پس از شروع
    empty
    Visual Analogue Scale
    empty
    مقیاس آنالوگ بصری
    empty
    #6
    Binge eating score
    empty
    امتیاز پرخوری
    empty
    First, 3 months and 6 months after the start of the study
    empty
    ابتدا، 3 ماه و 6 ماه پس از شروع
    empty
    Gormally Binge eating questionnaire
    empty
    پرسشنامه پرخوری گورمالی
    empty
    #7
    Eating Disorder Examination Score
    empty
    امتیاز آزمون اختلال خوردن
    empty
    First, 3 months and 6 months after the start of the study
    empty
    ابتدا، 3 ماه و 6 ماه پس از شروع
    empty
    Eating Disorder Examination Questionnaire (EDEQ)
    empty
    پرسشنامه آزمون اختلال خوردن
    empty

  • Secondary outcomes

    #1
    empty
    Glycosylated hemoglobin
    empty
    هموگلوبین گلیکوزیله
    empty
    First, 3 months and 6 months after the start of the study
    empty
    ابتدا، 3 ماه و 6 ماه پس از شروع مطالعه
    empty
    Blood test
    empty
    آزمایش خون
    #2
    empty
    Fasting blood sugar
    empty
    قند خون ناشتا
    empty
    First, 3 months and 6 months after the start of the study
    empty
    ابتدا، 3 ماه و 6 ماه پس از شروع مطالعه
    empty
    Blood test
    empty
    آزمایش خون
    #3
    empty
    Insulin
    empty
    انسولین
    empty
    First, 3 months and 6 months after the start of the study
    empty
    ابتدا، 3 ماه و 6 ماه پس از شروع مطالعه
    empty
    Blood test
    empty
    آزمایش خون
    #4
    empty
    Insulin resistance index
    empty
    شاخص مقاومت به انسولین
    empty
    First, 3 months and 6 months after the start of the study
    empty
    ابتدا، 3 ماه و 6 ماه پس از شروع مطالعه
    empty
    Formula
    empty
    فرمول
    #5
    empty
    Binge eating score
    empty
    امتیاز پرخوری
    empty
    First, 3 months and 6 months after the start of the study
    empty
    ابتدا، 3 ماه و 6 ماه پس از شروع مطالعه
    empty
    Gormally Binge eating questionnaire
    empty
    پرسشنامه پرخوری گورمالی

  • Recruitment centers

    #1
    Name of recruitment center - English: Dr. Hadaeq's Endocrine Clinic
    Name of recruitment center - Persian: کلینیک غدد دکتر حدائق
    Full name of responsible person - English: Farzad hadaegh
    Full name of responsible person - Persian: فرزاد حدائق
    Street address - English: Second Floor-No. 10-26 Alley-Qaem Mogham Farahani St
    Street address - Persian: خیابان قائم مقام فراهانی - کوچه 26 - پلاک 10 - طبقه دوم - واحد 6
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1638633915
    Phone: +98 21 8883 5403
    Fax:
    Email: fzhadaegh@endocrine.ac.ir
    Web page address:
    Name of recruitment center - English: Dr. Hadaeq's Endocrine Clinic
    Name of recruitment center - Persian: کلینیک غدد دکتر حدائق
    Full name of responsible person - English: Farzad hadaegh
    Full name of responsible person - Persian: فرزاد حدائق
    Street address - English: Second Floor, No.10, 26 Alley Qaem Mogham Farahani St
    Street address - Persian: خیابان قائم مقام فراهانی، کوچه 26، پلاک 10، طبقه دوم، واحد 6
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1638633915
    Phone: +98 21 8883 5403
    Fax:
    Email: fzhadaegh@endocrine.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Azita hekmatdoost
    Full name of responsible person - Persian: آزیتا حکمت دوست
    Street address - English: Faculty of Nutrition Sciences-Shahid Hafezi St-Quds town (West) Farhzadi Blvd-Tehran
    Street address - Persian: تهران- شهرک قدس (غرب)- بلوار شهید فرحزادی- خیابان شهید حافظی- دانشکده علوم تغذیه
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1981619573
    Phone: +98 21 2235 7483
    Fax:
    Email: info@nnftri.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Azita hekmatdoost
    Full name of responsible person - Persian: دکتر آزیتا حکمت دوست
    Street address - English: Faculty of Nutrition Sciences, Shahid Hafezi StQuds town (West) Farhzadi Blvd, Tehran
    Street address - Persian: تهران، شهرک قدس(غرب)، بلوار شهید فرحزادی، خیابان شهید حافظی، دانشکده علوم تغذیه
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1981619573
    Phone: +98 21 2235 7483
    Fax:
    Email: info@nnftri.ac.ir
    Web page address:

Protocol summary

Study aim
Investigating the effect of intensive lifestyle intervention including two diets, calorie-carbohydrate restricted diet and the time restricted feeding on glycemic biomarkers, eating disorders, and appetite, in overweight and obese type 2 diabetic patients
Design
The clinical trial has 2 intervention groups and a control group, without blinding, with 30 patients in each group. Randomized with 2 phases, each phase 3 months. Randomization will be done in the form of (1:1:1) through the method of randomized blocks.
Settings and conduct
Patients from the endocrinology clinic in Tehran. They enter the first phase. Then they enter the maintenance and monitoring phase. Measurements will be done at the beginning, 3 months, and 6 months after the start of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men and women 18-65 years old Less than 5 years duration of type 2 diabetes Use of at least one blood glucose-lowering medication HbA1c more than 10 percent Body mass index>45and<27 Exclusion criteria: Use of insulin, GLP-1 agonists, and SGLT-2 inhibitors, anti-obesity drugs, Recent routine HbA1c ≥10%, Weight loss of more than 5 kg in the last 6 months, kinds of diseases, Pregnancy or breastfeeding, or planning to become pregnant in the next 12 months, Drug abuse, Inability to perform physical activities
Intervention groups
phase1: Group1: Intermittent fasting group+calorie restriction and carbohydrate restriction+physical activity+ Behavior modification Group2:The calorie and carbohydrate restriction+physical activity+Behavior modification Control group: Standard care Phase2: Group1 and2: Weight maintenance diet Group3: Control group and standard care
Main outcome variables
Glycemic biomarkers (glycosylated hemoglobin, fasting blood sugar, fasting insulin, insulin resistance index) and appetite self-report score using a visual analog scale and eating disorder score

General information

Reason for update
Because this project is a thesis, professors' opinions, and needs assessment in diabetic patients during the implementation of the project, changes were made, including the addition of behavioral intervention and examination of the eating disorder factor in these patients.
Acronym
IRCT registration information
IRCT registration number: IRCT20230917059447N1
Registration date: 2023-09-24, 1402/07/02
Registration timing: registered_while_recruiting

Last update: 2026-05-13, 1405/02/23
Update count: 2
Registration date
2023-09-24, 1402/07/02
Registrant information
Name
Saba Mohammadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2235 7483
Email address
saba.mohammadpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intensive lifestyle intervention including two diets, calorie-carbohydrate restricted diet and the time restricted feeding on glycemic biomarkers, eating disorders, and appetite, in overweight and obese type 2 diabetic patients: a randomized controlled trial study
Public title
Comparison of the effect of intensive lifestyle intervention including two diets, calorie-carbohydrate restricted diet and the time restricted feeding on glycemic biomarkers, eating disorders, and appetite in type 2 diabetes patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women 18-65 years old Less than 5 years duration of type 2 diabetes (diagnosis based on 2 tests recorded at the diagnostic level, HbA1c and/or blood glucose) Use of at least one blood glucose-lowering medication HbA1c more than 43 mmol/mol (6.1%) with hypoglycemic drugs Body mass index (BMI) >45 and <27
Exclusion criteria:
Use of insulin Use of diabetes drugs from the category of GLP-1 agonists and SGLT-2 inhibitors Recent routine HbA1c ≥ 10% Weight loss of more than 5 kg in the last 6 months Impaired kidney function (eGFR < 60 ml per minute) Uncontrolled blood pressure (more than 160 mm Hg systolic or more than 100 mm Hg diastolic) Diseases including cancer - heart disease - gout - diagnosed eating disorders - patients with confirmed mental disorders Current treatment with Anti-obesity medications History of bariatric surgery Currently pregnant or lactating, or planning to become pregnant in the next 12 months Drug abuse Night shift workers Inability to perform physical activities
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
The purpose of randomization is to control the effect of all the influencing variables on the results of the study and prevent interference between treatment groups. Randomization will be done in the form of (1:1:1) through the randomized block method, and the sealed envelope method will be used to randomize, so that people will be randomly assigned to one of the three study groups. including providing a carbohydrate-restricted intermittent fasting diet, a continuous calorie-restricted diet with carbohydrate restriction, or receiving care based on guidelines (control). Due to the nature of the intervention under study, participants, intervention providers will be aware of the group allocation.
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 Shahid beheshti University of Medical Sciences
Street address
13th floor, Block A, Central Headquarters of the Ministry of Health Treatment and Medical Education, Quds town (west), between South Flamek and Zarafshan, Simai Iran St,Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2023-07-24, 1402/05/02
Ethics committee reference number
IR.SBMU.NNFTRI.REC.1402.038

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Appetite self-report score
Timepoint
First, 3 months and 6 months after the start of the study
Method of measurement
Visual Analogue Scale

2

Description
Eating Disorder Examination Score
Timepoint
First, 3 months and 6 months after the start of the study
Method of measurement
Eating Disorder Examination Questionnaire (EDEQ)

Secondary outcomes

1

Description
Height
Timepoint
Baseline
Method of measurement
Tape

2

Description
Weight
Timepoint
First, 3 months and 6 months after the start of the study
Method of measurement
Scale

3

Description
Body mass index
Timepoint
First, 3 months and 6 months after the start of the study
Method of measurement
Body composition analyzer

4

Description
Waist circumference
Timepoint
First, 3 months and 6 months after the start of the study
Method of measurement
Tape

5

Description
Hip circumference
Timepoint
First, 3 months and 6 months after the start of the study
Method of measurement
Tape

6

Description
Fat mass
Timepoint
First, 3 months and 6 months after the start of the study
Method of measurement
Body composition analyzer

7

Description
Fat free mass
Timepoint
First, 3 months and 6 months after the start of the study
Method of measurement
Body composition analyzer

8

Description
Diabetes remission
Timepoint
3 months and 6 months after the start of the study
Method of measurement
Glycosylated hemoglobin

9

Description
Total cholesterol
Timepoint
First, 3 months and 6 months after the start of the study
Method of measurement
Blood test

10

Description
Low-density lipoprotein
Timepoint
First, 3 months and 6 months after the start of the study
Method of measurement
Blood test

11

Description
High-density lipoprotein
Timepoint
First, 3 months and 6 months after the start of the study
Method of measurement
Blood test

12

Description
Triglyceride
Timepoint
First, 3 months and 6 months after the start of the study
Method of measurement
Blood test

13

Description
Emotional distress
Timepoint
First, 3 months and 6 months after the start of the study
Method of measurement
Problem Areas in Diabetes(PAID) Questionnaire

14

Description
Quality of life
Timepoint
First, 3 months and 6 months after the start of the study
Method of measurement
The quality-adjusted life year (QALY) Questionnaire

15

Description
Glycosylated hemoglobin
Timepoint
First, 3 months and 6 months after the start of the study
Method of measurement
Blood test

16

Description
Fasting blood sugar
Timepoint
First, 3 months and 6 months after the start of the study
Method of measurement
Blood test

17

Description
Insulin
Timepoint
First, 3 months and 6 months after the start of the study
Method of measurement
Blood test

18

Description
Insulin resistance index
Timepoint
First, 3 months and 6 months after the start of the study
Method of measurement
Formula

19

Description
Binge eating score
Timepoint
First, 3 months and 6 months after the start of the study
Method of measurement
Gormally Binge eating questionnaire

Intervention groups

1

Description
Intervention group: Intermittent fasting group plus calorie restriction and carbohydrate restriction+ Physical activity + Behavior modification
Category
N/A

2

Description
Intervention group: Calorie and carbohydrate restriction group+ Physical activity+ Behavior modification
Category
N/A

3

Description
Control group: Control group and standard care
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Hadaeq's Endocrine Clinic
Full name of responsible person
Farzad hadaegh
Street address
Second Floor, No.10, 26 Alley Qaem Mogham Farahani St
City
Tehran
Province
Tehran
Postal code
1638633915
Phone
+98 21 8883 5403
Email
fzhadaegh@endocrine.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Azita hekmatdoost
Street address
Faculty of Nutrition Sciences, Shahid Hafezi StQuds town (West) Farhzadi Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
info@nnftri.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research project of Shahid Beheshti University of Medical Sciences - Institute of Nutritional Research and Food Industries of the country
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parvin mirmiran
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition Sciences, Shahid Hafezi StQuds town (West) Farhzadi Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
۱۹۸۱۶۱۹۵۷۳
Phone
+98 21 2235 7483
Email
parvin.mirmiran@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sakineh Shab-bidar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Dietetics,Tehran University of Medical Sciences: No. 44, Hojat Dost St., Naderi St., Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1417935840
Phone
+98 21 8895 5975
Email
s_shabbidar@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saba Mohammadpour
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition Sciences, Shahid Hafezi StQuds town (West) Farhzadi Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
Saba_mp@yahoo.com

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
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