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To study the differences in stool microbes, integrity and absorptive capacity of human gut in obese and diabetes mellitus patients.

Serum zonulin level, gut microbiota dysbiosis, and whole gut sugar permeability assessment in diabetes mellitus evolution

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/07/034628
Enrollment
60
Registered
2021-07-06
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R739- Hyperglycemia, unspecified Health Condition 2: E669- Obesity, unspecified Health Condition 3: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: not applicable: not applicable

Sponsors

Amol N Patil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult with age >18 to 75 (either sex) 2. Giving written informed consent for study participation

Exclusion criteria

Exclusion criteria: 1. Taking any diabetic medication like Insulin or OHA (oral hypoglycemic agents) 2. Pregnancy 3. Celiac Disease 4. Any Malabsorptive disorders (pancreatic insufficiency) 5. Chronic kidney disease (eGFR 6. On glucocorticoid therapy, immunosuppressive agents, GLP-1 analogues, SGLT2 i, Probiotics 7. Active malignancy 8. Bariatric surgery 9. Hypothyroid 10. Type 1 diabetes

Design outcomes

Primary

MeasureTime frame
1.To compare the Serum Zonulin levels in obese non diabetes, obese prediabetes and newly diagnosed diabetes patientsTimepoint: baseline estimation only—

Secondary

MeasureTime frame
1. To compare the fecal gut microbiome changes in obese non diabetes, with obese prediabetes and newly diagnosed diabetes patients. 2. To compare the whole gut permeability of oligosaccharide/disaccharide in obese non diabetes, with obese prediabetes and newly diagnosed diabetes patients. Timepoint: baseline estimation only—

Countries

India

Contacts

Public ContactAnkit Kumar

PGIMER Chandigarh

seeamol83@gmail.com9990245973

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026