IRCT | The effects of 8 weeks of high-intensity interval cardio yoga and traditional interval hatha yoga on oxidative stress, inflammation, lipid markers, glycemic control, BDNF and cortisol in type 2 diabetic women: a controlled, randomized Clinical Trial

Protocol summary

Study aim: Determining the effect of yoga practice at two different intensities on metabolic indices, anthropometry, inflammation, oxidative stress, cortisol, BDNF, mental health, and functional status in women with type 2 diabetes.
Design: This study will be a randomized, double-blind, controlled, three-arm trial involving 39 women with type 2 diabetes. Participants will be randomly assigned to one of three groups: HIICY (n=13), TIHY (n=13), and a control group (n=13). Simple randomization will be performed using a computer.
Settings and conduct: Yoga groups will participate in training sessions three days a week for 8 weeks under the supervision of a yoga instructor at the University of Tabriz. Nurses and laboratory technicians will be blinded during sample collection and laboratory analyses
Participants/Inclusion and exclusion criteria: Thirty-nine women with type 2 diabetes, having had diabetes for more than 6 months, with physical inactivity and a body mass index (BMI) of over 25 kg/m² in the past three months are eligible for inclusion. Those with a history of cardiovascular diseases, kidney disorders, or taking anti-inflammatory medications or laxatives are excluded.
Intervention groups: Intervention group one: High-Intensity Interval Cardio Yoga; Intervention group two: Traditional Hatha Yoga exercises; Control group: No exercise. Based on tempo, each movement will be 1.5 seconds for HIICY and 3 seconds for TIHY, with active recovery between sets. In addition, there will be meditation and breathing exercises for each group. The control group will not have training sessions.
Main outcome variables: High-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor alpha (TNF-α), interleukin-6, interleukin-10, cortisol, metabolic indices, antioxidant capacity (TAC), malondialdehyde (MDA), brain-derived neurotrophic factor (BDNF), functional tests, anthropometric index and mental health

General information

Reason for update
Acronym: BDNF, BMI FFM FM%, FM, HRR, hs-CRP, IL, IPAQ, MDA, NF-kβ, TAC, TNF-α, LDL, HDL,TG, VOMAX,HbA1c,TC, FBS, HIICH, HY, HR, QUICK, IPAQ, ROS, T2DM, ANCOVA, HFIAS, QHQ-28, LDL-c, LDL-ox, DQOL, DASS
IRCT registration information: IRCT registration number: IRCT20250207064682N1

Registration date: 2025-04-02, 1404/01/13

Registration timing: prospective

Last update: 2025-04-02, 1404/01/13

Update count: 0
Registration date: 2025-04-02, 1404/01/13

Registrant information: Name

Mostafa khani

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 914 926 3371

Email address

khani_ms@yahoo.com

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2025-04-08, 1404/01/19
Expected recruitment end date: 2025-04-19, 1404/01/30
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: The effects of 8 weeks of high-intensity interval cardio yoga and traditional interval hatha yoga on oxidative stress, inflammation, lipid markers, glycemic control, BDNF and cortisol in type 2 diabetic women: a controlled, randomized Clinical Trial

Public title: The effect of two kinds of yoga on lipid profile, inflammation, oxidative stress, cortisol and BDNF in type 2 diabetic women
Purpose: Prevention
Inclusion/Exclusion criteria: Inclusion criteria:

Having diabetic for>6 months Having a stable diet and currently taking oral antidiabetic medication Sedentary (<30-minutes twice a week of high-intensity exercise, e.g., running, yoga- and mind-body movement therapies (MBMTs)) Having had a body mass index (BMI) of >25 kg/m2for the past 3 mo Diabetic will be defined as having a fasting glucose level of 126 mg/dL

Exclusion criteria:

Subjects will be excluded if they had a history of gastrointestinal, if they had renal, thyroid or liver disturbance; if they are pregnant or lactating pancreatic, or cardiovascular disease; If they are currently taking prebiotics, probiotics, antibiotics, antacids, alcohol, antidiarrheal, anti-inflammatory or laxative medicines If they will not attend training for more than three sessions; If they change their oral antidiabetic medication during the intervention
Age: From 35 years old to 65 years old
Gender: Female

Phase

N/A

Groups that have been masked

Outcome assessor
Data analyser

Sample size

Target sample size: 39

Randomization (investigator's opinion)

Randomized

Randomization description

Simple randomization will be used to assign participants to intervention and control groups. An independent statistician will generate a computer-produced sequence of random numbers, which will be provided to an external staff member who is not involved in the study’s procedures. Participants will receive consecutive numbers after baseline measurements are taken. Participants will also be matched on BMI and age.

Blinding (investigator's opinion)

Double blinded

Blinding description

Participants and the yoga instructor will not be blinded to group assignment. However, nurses and lab technicians will be blinded during sample collection and laboratory analysis. The data analyst will be unblinded after all laboratory analyses are complete.

Placebo

Not used

Assignment

Parallel

Other design features

We will use the International Physical Activity Questionnaire (IPAQ—Short Version) to assess physical health and physical activity levels. A 3-day food record will be explained to the subjects (two weekdays and one weekend), and after participants report their food and beverage intake, the data will be analyzed using the program “Nutritionist 4”

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics Committee of the University of Tabriz

Street address

Azerbaijan Province, Tabriz, 29 Bahman Boulevard

City

Tabriz

Province

East Azarbaijan

Postal code

5164736931
Approval date: 2025-01-12, 1403/10/23
Ethics committee reference number: IR.TABRIZU.REC.1403.139

Health conditions studied

1

Description of health condition studied: Women with type 2 diabetes
ICD-10 code: E08
ICD-10 code description: Diabetes mellitus due to underlying condition

Primary outcomes

1

Description: Changes in high-sensitivity C-reactive protein (hs-CRP)
Timepoint: First intervention and 2 months after intervention.
Method of measurement: At the beginning and end of the trial, 10 mL of venous blood samples will be collected between 9:00 AM and 7:00 AM following an overnight fast. The immunoturbidimetry assay will be utilized to characterize the serum hs-CRP level (Pars Azmoon Co., Tehran, Iran).

2

Description: Tumor necrosis factor-alpha (TNF-α)
Timepoint: First intervention and 2 months after intervention.
Method of measurement: At the beginning and end of the trial, 10 mL of venous blood samples will be collected between 9:00 AM and 7:00 AM following an overnight fast. Based on the biotin double antibody sandwich technique, commercial enzyme-linked immunosorbent assay (ELISA) kits (Diaclone, Besancon, France) will be used to analyze the levels of TNF-α.

3

Description: Changes in Interleukin 6 (IL-6)
Timepoint: First intervention and 2 months after intervention.
Method of measurement: At the beginning and end of the trial, 10 milliliters of venous blood samples will be collected between 7 AM and 9 AM after an overnight fast. Based on a double biotin sandwich antibody method, commercial ELISA kits (Diaclone, Besançon, France) will be used to analyze IL-6 levels.

4

Description: Changes in Interleukin 10 (IL-10)
Timepoint: First intervention and 2 months after intervention.
Method of measurement: At the beginning and end of the trial, 10 milliliters of venous blood samples will be collected between 7 AM and 9 AM after an overnight fast. Based on a double biotin sandwich antibody method, commercial ELISA kits (Diaclone, Besançon, France) will be used to analyze IL-10 levels.

5

Description: Changes in Low-Density Lipoprotein (LDL)
Timepoint: First intervention and 2 months after intervention.
Method of measurement: At the beginning and end of the trial, 10 ml of venous blood samples will be collected between 9 am and 7 am after an overnight fast. LDL concentration will be determined by enzymatic colorimetric methods (Cholesterol CHOD-PAP and Trig lycerides GPO-PAP, Pars-Azmone, IRI) on an automated analyzer (Abbott, model Alcyon300, USA), serum LDL-c will be determined based on the Friedewald equation. TC/HDL-c and LDL-c/HDL-c ratios will determine the relative risk of coronary artery disease, they will also be calculated.

6

Description: Changes in glycosylated hemoglobin (HbA1c)
Timepoint: First intervention and 2 months after intervention.
Method of measurement: Initially and at the end of the trial, 10 mL of venous blood sample will be collected between 7 and 9 AM after an overnight fast. The level of Hemoglobin A1c (HbA1c) will be measured using the HPLC D-10 chromatography system (Bio-Rad Laboratories, Hercules, California, USA).

7

Description: Changes in insulin concentration
Timepoint: First intervention and 2 months after intervention.
Method of measurement: At the beginning and at the end of the trial, 10 mL of venous blood will be collected between 7:00 and 9:00 AM after an overnight fast. Serum insulin will be measured using the chemiluminescent immunoassay method (LIAISON analyzer 310360; Diasorin S.P.A, Vercelli, Italy).

8

Description: Changes in insulin resistance (HOMA-IR)
Timepoint: First intervention and 2 months after intervention.
Method of measurement: The evaluation of the insulin resistance homeostasis model (HOMA-IR) was calculated using the following formula: [Fasting insulin (μU/mL) × FPG (mg/dL)]/405.

9

Description: Changes in Antioxidant Capacity (TAC)
Timepoint: First intervention and 2 months after intervention.
Method of measurement: At the beginning and end of the trial, 10 milliliters of venous blood will be collected between 9 AM and 7 AM after an overnight fast. TAC levels will be assessed using spectrofluorimetric and colorimetric methods ( Randox kits, Randox Laboratory, UK).

10

Description: Changes in Malondialdehyde (MDA)
Timepoint: First intervention and 2 months after intervention.
Method of measurement: At the beginning and end of the trial, 10 milliliters of venous blood will be collected between 7 and 9 AM after an overnight fast. The levels of malondialdehyde (MDA) will be assessed using spectrophotometric and colorimetric methods ( Kontron, model SFM 25A, Italy).

11

Description: Sleep quality
Timepoint: First intervention and 2 months after intervention.
Method of measurement: It will be measured using the Pittsburgh Sleep Quality Index (PSQI).

12

Description: General health
Timepoint: First intervention and 2 months after intervention.
Method of measurement: It will be measured using the General Health Questionnaire (GHQ-28).

13

Description: Guality of life
Timepoint: First intervention and 2 months after intervention.
Method of measurement: It will be measured using the Diabetes Quality of Life Questionnaire developed by Thomas et al. (DQOL).

14

Description: Food insecurity,
Timepoint: First intervention and 2 months after intervention.
Method of measurement: It will be measured using the General Health Questionnaire (GHQ-28).

15

Description: Depression, anxiety, stress
Timepoint: First intervention and 2 months after intervention.
Method of measurement: It will be measured using the Depression, Anxiety, and Stress Scale (DASS-21).

16

Description: Blood pressure
Timepoint: First intervention and 2 months after intervention.
Method of measurement: It will be measured using a mercury sphygmomanometer.

17

Description: Changes in cortisol concentration
Timepoint: First intervention and 2 months after intervention.
Method of measurement: At the beginning and end of the trial, 10 milliliters of venous blood samples will be collected between 7 and 9 AM after an overnight fast. Serum cortisol will be measured using ELISA kits (eBioscience, San Diego, California) according to the manufacturer’s instructions.

18

Description: Insulin Sensitivity (QUICKI)
Timepoint: First intervention and 2 months after intervention.
Method of measurement: Insulin sensitivity will be assessed using the QUICKI index, calculated with the following formula: QUICKI = [log fasting glucose (mg/dL) + log fasting insulin (μU/mL)] - 1.

19

Description: brain-derived neurotrophic factor (BDNF)
Timepoint: First intervention and 2 months after intervention.
Method of measurement: At the beginning and end of the trial, 10 ml of venous blood samples will be collected between 9 am and 7 am after an overnight fast. Serum BDNF concentrations will be measured using ELISA kits (Human BDNF ELISA Kit, Boston, USA;) according to the manufacturer's instructions.

20

Description: fasting blood glucose (FBS)
Timepoint: First intervention and 2 months after intervention.
Method of measurement: At the beginning and end of the trial, 10 ml of venous blood samples will be collected between 9 am and 7 am after an overnight fast. Fasting plasma glucose (FPG) concentration will be measured enzymatically using an Abbot ModelAclyon 300 autoanalyzer (USA) with a Pars Azmoun kit (Tehran, Iran).

21

Description: Balance test
Timepoint: First intervention and 2 months after intervention.
Method of measurement: Functional tests: Rhomborig (eyes closed), Rhomborig (eyes open),

22

Description: Flexibility test
Timepoint: First intervention and 2 months after intervention.
Method of measurement: sit-and-reach test (trunk flexibility), shoulder flexibility,

23

Description: Muscular endurance test
Timepoint: First intervention and 2 months after intervention.
Method of measurement: 30-second hand raising test, 30-second chair standing and sitting test

24

Description: High-density lipoprotein (HDL)
Timepoint: First intervention and 2 months after intervention.
Method of measurement: Initially and at the end of the trial, 10 mL of venous blood sample will be collected between 7 and 9 AM after an overnight fast. The level of HDL will be measured using an automatic analyzer (Abbot Aclyon 300, USA).

25

Description: Triglycerides
Timepoint: First intervention and 2 months after intervention.
Method of measurement: Initially and at the end of the trial, 10 mL of venous blood sample will be collected between 7 and 9 AM after an overnight fast. The level of Triglycerides will be measured using an automatic analyzer (Abbot Aclyon 300, USA).

Secondary outcomes

1

Description: Body weight changes
Timepoint: First intervention and 2 months after intervention.
Method of measurement: The patients' weight before and after the intervention will be measured using a Seca dial scale made in Germany with an accuracy of 100 grams with minimal clothing and no shoes. The patients' height will also be measured using a tape measure mounted on the wall with an accuracy of 0.1 cm.

2

Description: Waist circumference
Timepoint: First intervention and 2 months after intervention.
Method of measurement: Waist circumference was measured using a non-elastic tape measure in the standing position at the midpoint of the lower edge of the lowest rib and the superior border of the iliac crest after normal breathing (without clothing). Waist circumference was measured according to standard methods described elsewhere.

3

Description: Hip circumference
Timepoint: First intervention and 2 months after intervention.
Method of measurement: The circumference of the hips will also be measured at the area of the greatest curvature of the buttocks without pressing the skin.

4

Description: Body composition (FFM, FM, and FM%)
Timepoint: First intervention and 2 months after intervention.
Method of measurement: A body composition analyzer (Tanita BC-418, Tanita Corp., Tokyo, Japan) will be used to measure the participants' body composition.

5

Description: Maximum oxygen consumption (VO2 max)
Timepoint: First intervention and 2 months after intervention.
Method of measurement: Aerobic fitness will also be assessed with a standardized submaximal treadmill walking protocol, which will be modified from the Balke 27 maximal protocol, to be appropriate for participants with various chronic conditions.

6

Description: Body Mass Index (BMI)
Timepoint: First intervention and 2 months after intervention.
Method of measurement: BMI will also be calculated using the relevant formula by dividing weight (kg) by height squared (m2).

Intervention groups

1

Description: This study will be a three-arm randomized controlled trial. Participants will be randomly assigned to one of three groups. The first intervention group: High-Intensity Interval Cardio Yoga (HIICY; n=13). HIICY group participants will train three days a week for 8 weeks. All training sessions will be conducted under the supervision of a qualified yoga instructor at the Faculty of Physical Education and Sports Sciences, University of Tabriz. For both training sessions and the HIICY sequence, the Surya Namaskar B sequence, which includes 19 physical exercises (asanas), will be used. Based on tempo, each movement will last 1.5 seconds for HIICY, using a metronome. The total duration for both styles will be 60 minutes, including 2 sets of 10 minutes of HIICY and a 10-minute active recovery between sets. Active recovery will be performed by walking at 40-45% of estimated HRmax, as suggested in a previous study, followed by 7-10 minutes of breathing and 5-10 minutes of guided relaxation. Participants will record the start and end of their yoga sessions on a Fitbit Sense FB512GLWT device and will fill out a one-minute post-session report, recording their heart rate, effort, and impact.
Category: Lifestyle

2

Description: The second intervention group: Traditional Hatha Yoga (TIHY; n=13), TIHY group participants will train three days a week for 8 weeks. All training sessions will be conducted under the supervision of a qualified yoga instructor at the Faculty of Physical Education and Sports Sciences, University of Tabriz. For both training sessions and the TIHY sequence, the Surya Namaskar B sequence, which includes 19 physical exercises (asanas), will be used. Based on tempo, each movement will last 3 seconds for TIHY, using a metronome. The total duration for both styles will be 60 minutes, including 2 sets of 10 minutes of TIHY and a 10-minute active recovery between sets. Active recovery will be performed by walking at 40-45% of estimated HRmax, as suggested in a previous study, followed by 7-10 minutes of breathing and 5-10 minutes of guided relaxation. Participants will record the start and end of their yoga sessions on a Fitbit Sense FB512GLWT device and will fill out a one-minute post-session report, recording their heart rate, effort, and impact.
Category: Lifestyle

3

Description: Control group: Participants assigned to the control group did not have structured training sessions, but for ethical reasons, they were invited to attend an introductory session where standard advice on general physical activity guidelines was provided. In addition, every 2 weeks, both the training and control groups would meet for thematic sessions on topics such as nutrition or physical activity to improve trial adherence.
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Diabetes Association of Iran

Full name of responsible person

Mostafa Khani

Street address

pastor

City

Tabriz

Province

East Azarbaijan

Postal code

5138883716

Phone

+98 905 799 0847

Email

khani_ms@yahoo.com‏

1

Sponsor: Name of organization / entity

University of Tabriz

Full name of responsible person

Jalal Shiri

Street address

Tabriz, Abersan 29 Bahman Blvd.

City

Tabriz

Province

East Azarbaijan

Postal code

5164736931

Phone

+98 905 799 0847

Email

khani_ms@yahoo.com‏
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: No
Title of funding source: University of Tabriz
Proportion provided by this source: 10
Public or private sector: Private
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

University of Tabriz

Full name of responsible person

Mostafa Khani

Position

Assistant Professor

Latest degree

Ph.D.

Other areas of specialty/work

exercise physiology

Street address

Tabriz

City

Tabriz

Province

East Azarbaijan

Postal code

5164736931

Phone

09067990847

Email

khani_ms@yahoo.com‏

Person responsible for scientific inquiries

Contact: Name of organization / entity

University of Tabriz

Full name of responsible person

Sanaz Salahpour

Position

Master's student in exercise physiology

Latest degree

Master

Other areas of specialty/work

Exercise physiology

Street address

Tabriz

City

Tabriz

Province

East Azarbaijan

Postal code

5138883716

Phone

09067990847

Email

salapoursanaz@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

University of Tabriz

Full name of responsible person

Sanaz Salahpour

Position

Master's student in exercise physiology

Latest degree

Master

Other areas of specialty/work

Exercise physiology

Street address

Pastor

City

Tabriz

Province

East Azarbaijan

Postal code

5138883716

Phone

+98 905 799 0847

Email

salapoursanaz@gmail.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: No - There is not a plan to make this available
Data Dictionary: No - There is not a plan to make this available

The effects of 8 weeks of high-intensity interval cardio yoga and traditional interval hatha yoga on oxidative stress, inflammation, lipid markers, glycemic control, BDNF and cortisol in type 2 diabetic women: a controlled, randomized Clinical Trial