NCT05695651

Brief Summary

  • Explore the association between Triglyceride glucose index and HOMA IR with the risk of macrovascular and microvascular complications of type 2 diabetes.
  • Which shows better performance for assessing insulin resistance Triglyceride glucose index or HOMA-IR in clinical practice regardless of diabetes status

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

February 7, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2025

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

1.9 years

First QC Date

January 10, 2023

Last Update Submit

January 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Investigate the association between TyG index and HOMA IR with the risk of macrovascular and microvascular complications of type 2 diabetes

    Investigate the association between TyG index and HOMA IR with the risk of macrovascular and microvascular complications of type 2 diabetes

    baseline

Secondary Outcomes (1)

  • Percentage of diabetic patients who developed vascular complications.

    baseline

Interventions

TyG index was calculated as formula: ln\[fasting triglycerides (mg/dL) × fasting plasma glucose (mg/dL)/2\]. an insulin resistance score (HOMA-IR) was computed with the formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance).

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients were diagnosed with diabetes type 2 According to American Diabetes Association

You may qualify if:

  • Patients were diagnosed with diabetes type 2 According to American Diabetes Association

You may not qualify if:

  • years or young
  • Type 1 diabetes or other special types of diabetes
  • Suffering from acute complications of diabetes, severe chronic complications, or malignant tumors
  • Patients with a diagnosis of urinary tract infection, renal calculi, or primary renal disease.
  • Evidence of chronic kidney disease.
  • Evidence of Diabetic Kidney Disease and/or Diabetic Nephropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Sally Mamdoh Nathan Wasilly, master

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
sahel sleem - assiut

Study Record Dates

First Submitted

January 10, 2023

First Posted

January 25, 2023

Study Start

February 7, 2023

Primary Completion

January 7, 2025

Study Completion

March 7, 2025

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share