Relation between Obesity and Blood insulin level

Not yet recruiting

• Conditions: Other obesity,

• Registration Number: CTRI/2023/04/052071
• Lead Sponsor: Dr Yash Gupta

Brief Summary

AimAn Aetiopathological study of Sthoulya in relation to Obesity with special reference to Blood Insulin Level.Objectives-• To Study SthoulyaVyadhi in details.• To study Obesity in details.• To elaborate the relation of blood insulin level in obesity and sthoulyaVyadhi. Review of literatureThe literary sources will be collected from Ayurvedic classical text and published articles in reputed journals regarding Sthoulya, & medorogaj. The literary sources will be collected from modern text and published article in reputed journals regarding obesity. HYPOTHESIS:Null Hypothesis (H0) –There is no relation between Sthoulya (Obesity) and Blood Insulin LevelAlternative Hypothesis (H1) – There is relation between Sthoulya (Obesity) and Blood Insulin Level. MATERIALS AND METHODS:• Type of Study - Observational Clinical Study.• Sample Size - 100 Patients.• Place of Study- D Y Patil Ayurvedic Hospital, Nerul, Navi Mumbai.Criteria for Assessment –1. Inclusion Criteria – - Patients between age group of 18 to 60 years irrespective of sex. - Patients Fulfilling criteria of assessment of Sthoulya and Obesity i.e., BMI more than 30. 2. Exclusion Criteria – - Known and complicated cases of DM, HTN, IHD, Malignancy, HIV-AIDS, Hypothyroidism, Crushing’s syndrome and Pregnancy.Assessment Criteria –1. Subjective Criteria – - Symptoms of Sthoulya (Obesity)would be taken along with their gradation. 2. Objective Criteria – 1. Blood Insulin Level- Fasting & Post prandial. 2. BMI, Hip Waist Ratio, Skin Fold Test. Assessment Criteria of Sthoulya:Sr. No.Subjective Parameters G0 G1 G2 G3 G4 Observed scoreOnset and Duration1 KshudraShwasa (Gasping for air)No difficulty in breathing Mild Moderate Severe Very Severe2 Trushna (Excessive thirst)Never Rarely SometimesMost times/Often3 Moha (Delusion)None Not interfering with functionsInterfering with functions but not interfering with daily activitiesInterfering with daily activities.Bedridden4 Swapna krathana (Snoring)Absent lowfrequency, single syllable snorelow and middle frequency duplex soundhigh and middle frequency duplex soundtriplex sounds with high, low, and middlefrequency5 Saada (Exhustion)None Minimal Moderate Very hard Maximum effort6 Kshut (Excessive Hunger)Normal Starting to feel a little hungryPretty hungry, stomach is growling a littleVery hungry, cranky, low energy, lots of stomach growlingStarving, weak, dizzy7 Sweda (Excessive perspiration)Normal Never noticeable but never interferes with daily activitiesNoticeable but sometimes interferes with daily activitiesBarely tolerable and frequently interferes with daily activities.Intolerable and always interferes with daily activities.8 Durgandha (Foul body odor)None. Tolerable MildlytolerableBarely tolerableIntolerable. 9 Alpanmainthun (Less sexual strength)Normal Decreased.Severe loss.Unable to perform.10 ChalaSphikaudarastanatwam(abnormal fat acumalation eg – hip, abdomen & breast)Detectable by study participantDetectable on physical examination.Disfiguring or obvious changes on casual – visual examination. - -11 MedomamsaAtivriddhiNone. Mild Moderate Severe Very Severe12 Anutshaha - Slight Marked Severe Any activity increases symptoms. Grades G0 absent,G1 Mild symptomatology,G2 Moderate symptomatologyG3 Severe symptomatologyG4 Very severe symptomatology. Symptoms Score System â–¬ Gradations of most of the symptoms are based on “NCI CTC Toxicity scale Version 2.0 (April,1999)†and “Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0; Published by: U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES, National Institutes of Health, National Cancer Institute; on May 28, 2009 (v4.03: Jun 14, 2010)â€. Assessment Criteria of Obesity:Classification of Obesity BMIPre-obese 25.00- 29.99Obese ≥30.00Obese class I 30.00 -34.99Obese class II 35.00 – 39.99Obese class III ≥40.00. Assessment Criteria of Waist Hip Ratio:Health Risk Men WomenLow 0.95 or lower 0.80 or lowerModerate 0.96–1.0 0.81–0.85High 1.0 or higher 0.86 or higher. Assessment Criteria of Skin Fold Test:Gender Excellent Good Average Below averagePoorMale 60 - 80 81 - 90 91-110 111-150 150+Female 70-90 91-100 101-120 121-150 150+. Assessment Criteria of Blood Insulin:Blood Insulin SI Units Mild Moderate SevereFasting < 174 pmol/L 175-185 186-190 More than 190Post Prandial2 hour after Meal111-1153 pmol/L1153-1160 1161-1170 More than 1170 pmol/L.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-04-27
• Study Start: 2023-04-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients between age group of 18 to 60 years irrespective of sex.
• Patients Fulfilling criteria of assessment of Sthoulya and Obesity i.e., BMI more than 30.

Exclusion Criteria

Known and complicated cases of DM, HTN, IHD, Malignancy, HIV-AIDS and Pregnancy.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establish relation between blood insulin level and obesity.	12 weeks

Trial Locations

Locations (1)

D.Y. Patil School Of Ayurveda and hospital, DY Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai.; 🇮🇳 Thane, MAHARASHTRA, India

D.Y. Patil School Of Ayurveda and hospital, DY Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai.

🇮🇳Thane, MAHARASHTRA, India

Dr Yash Gupta

Principal investigator

9823382882

guptayash020@gmail.com