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Completed

NCT Number: NCT07626775

To Assess the Prevalence, Management Practices, and Clinical Outcomes Associated With Hyperglycemia Among Hospitalized Patients, With a Particular Focus on the Interplay Between Metabolic Biomarkers, Nutritional Status, and Body Composition

This was a prospective, observational cross-sectional study conducted at a tertiary care private hospital in India. The study was designed to comprehensively evaluate the prevalence, management strategies, and clinical outcomes of in-hospital hyperglycemia among adult inpatients. The study also explored the associations of metabolic biomarkers-fetuin-A and fibroblast growth factor-21 (FGF-21) as well as sarcopenic obesity and nutritional factors with clinical outcomes, including length of hospital stay (LOS), complications, and mortality. Institutional Ethics Committee approval was obtained prior to study initiation, and written informed consent was secured from all participants

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Key information

Conditions

Diabete Mellitus Diabete Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperglycaemia (Diabetic) Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Division Of Endocrinology & Diabetes

Gurgaon, Haryana, 122001, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients aged ≥18 years.
  • Patients with known or newly diagnosed type 2 diabetes mellitus (T2DM) or those presenting with hyperglycemia (random blood glucose ≥140 mg/dL) during hospitalization.
  • Both medical and surgical inpatients admitted for ≥24 hours

Exclusion criteria

  • Pregnant or lactating women.
  • Patients with type 1 diabetes mellitus or other specific types of diabetes (e.g., pancreatogenic, drug-induced).
  • Patients with chronic liver disease unrelated to diabetes or hepatic dysfunction secondary to viral hepatitis, autoimmune hepatitis, or alcohol abuse.
  • Critically ill patients requiring palliative care or those with advanced malignancy

Treatment and study plan

Primary outcomes

  1. To determine the prevalence of hyperglycemia

    Time frame: 10 Days

    To determine the prevalence of hyperglycemia and pre-existing or newly diagnosed type 2 diabetes mellitus (T2DM) among hospitalized patients

  2. Assess clinical outcomes associated with hyperglycemia

    Time frame: 10 Days

    To assess clinical outcomes associated with hyperglycemia, including in-hospital complications, mortality, need for critical care support, and length of hospital stay (LOS)

Secondary outcomes

  1. Prevalence of sarcopenic obesity

    Time frame: 10 Days

    To assess the prevalence of sarcopenic obesity among diabetic and hyperglycemic patients, and to determine its association with metabolic dysfunction and adverse outcomes

  2. Analyze serum biomarker level fetuin-A

    Time frame: 10 Days

    To analyze serum biomarker level fetuin-A and correlate them with severity of metabolic dysregulation .Serum fetuin-A levels were measured using commercially available enzyme-linked immunosorbent assay (ELISA) kits

  3. Analyze serum biomarker level FGF-21

    Time frame: 10 Days

    To analyze serum biomarker levels FGF-21 and correlate them with severity of metabolic dysregulation.Serum FGF-21 levels were measured using commercially available enzyme-linked immunosorbent assay (ELISA) kits

  4. Analyze serum biomarker level FGF-21

    Time frame: 10 Days

    To analyze serum biomarker levels FGF-21 and correlate them with liver fibrosis indices.Serum FGF-21 levels were measured using commercially available enzyme-linked immunosorbent assay (ELISA) kits

  5. Analyze serum biomarker level fetuin-A

    Time frame: 10 Days

    To analyze serum biomarker level fetuin-A and correlate them with liver fibrosis indices .Serum fetuin-A levels were measured using commercially available enzyme-linked immunosorbent assay (ELISA) kits

  6. To assess Impact of diet

    Time frame: 10 Days

    To assess the impact of adequacy of dietary on glycemic control and recovery, will measure the Sugar level at Before Breakfast,Before Lunch,Before Dinner

Sponsors and collaborators

Lead sponsor

Medanta, The Medicity, India

Other

Registry information

Acronym: CLIOHA

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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