Trial · NCT07074379
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Acute Pancreatitis Incidence | 12 months | The incidence of acute pancreatitis assessed by Revised Atlanta Classification over a 12-month period following randomization. |
| Secondary | Severity of Acute Pancreatitis | 12 months | The severity of acute pancreatitis episodes that occur within 12 months post randomization. Severity will be graded according to the Atlanta Classification criteria, which categorizes pancreatitis into mild, moderate, and severe based on clinical and imaging findings. |
| Secondary | Incidence and Severity of Pancreatic Pain | 12 months | The incidence and severity of pancreatic pain over a 12-month period. Pain severity will be measured using the Visual Analogue Scale (VAS), where patients rate their pain on a scale from 0 (no pain) to 10 (worst possible pain). |
| Secondary | Number of Acute Pancreatitis Episodes | 12 months | |
| Secondary | Number of pancreatic pain episodes | 12 months | |
| Secondary | Fecal Elastase-1 Level | 12 months | This outcome assesses pancreatic exocrine function by measuring fecal elastase-1 (FE-1) levels |
| Secondary | Glycosylated Hemoglobin Level | 12 months | This outcome measure evaluates the percentage of hemoglobin that is glycosylated, reflecting the average blood glucose levels over the past 2 to 3 months. It is a key indicator of long-term glycose level in patients. |
| Secondary | Fasting Blood Glucose Level | 12 months | This outcome measure assesses the level of glucose in the blood after an overnight fast. Fasting glucose is a standard test for diagnosing diabetes and monitoring diabetes control. It provides a snapshot of the body's ability to manage glucose without the influence of food. |
| Secondary | Fasting C-Peptide Concentration | 12 months | This outcome measure determines the concentration of C-peptide in the blood during a fasting state. C-peptide is a byproduct of insulin production and provides an index of endogenous insulin secretion. It is useful for assessing insulin production capacity. |
| Secondary | Fasting Insulin Concentration | 12 months | |
| Secondary | C-peptide Area Under the Curve (AUC) Post MMTT | 12 months | This outcome measures the total exposure to C-peptide over the first 2 hours following a mixed meal tolerance test (MMTT). The AUC is calculated using Riemann sums based on the midpoint of each interval (0, 30, 60, 90, and 120 minutes). This metric is crucial for assessing the overall insulin secretion capacity of the islets. |
| Secondary | Glucose Area Under the Curve (AUC) Post MMTT | 12 months | This outcome assesses the total glucose exposure over the first 2 hours following a Mixed Meal Tolerance Test (MMTT). The AUC is determined using Riemann sums based on the midpoint of each interval (0, 30, 60, 90, and 120 minutes). This metric is essential for evaluating the body's glucose handling ability and the effectiveness of glucose control. |
| Secondary | Insulin Area Under the Curve (AUC) Post MMTT | 12 months | This outcome measures the total insulin exposure over the first 2 hours following a Mixed Meal Tolerance Test (MMTT). The AUC is calculated using Riemann sums based on the midpoint of each interval (0, 30, 60, 90, and 120 minutes). This metric is vital for assessing the overall insulin secretion response to a meal and the effectiveness of insulin production. |
| Secondary | Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | 12 months | The HOMA-IR is calculated from fasting glucose and fasting insulin levels obtained during the MMTT. It provides an estimate of insulin resistance and is calculated using the formula: HOMA-IR= (fasting glucose × fasting insulin)/405. This index is crucial for understanding the body's insulin sensitivity. |
| Secondary | Homeostatic Model Assessment of β-cell Function (HOMA-b) | 12 months | HOMA-b is determined by the formula HOMA b = (fasting insulin × 360)/(fasting glucose - 63) to assess insulin secretion. It provides an estimate of the β-cell function in response to fasting glucose levels. |
| Secondary | Insulinogenic Index Post MMTT | 12 months | The insulinogenic index is a measure of the early insulin response to a glucose challenge, calculated as (Δinsulin30-0min / Δglucose30-0min). It reflects the capacity of the β-cells to secrete insulin in response to a rise in blood glucose levels. |
| Secondary | C-peptide Secretion Index Post MMTT | 12 months | This index is calculated by replacing insulin with C-peptide in the insulinogenic index formula, i.e., (ΔC-peptide30-0min / Δglucose30-0min). It serves as a measure of the early C-peptide response to a glucose challenge, providing information about the secretory capacity of the islets. |
| Secondary | Disposition Index for C-peptide | 12 months | The disposition index for C-peptide is calculated as (ΔC-peptide30-0min / Δglucose30-0min) × (1 / fasting C-peptide). It represents the ratio of insulin or C-peptide secretion to sensitivity and is an important indicator of the overall β-cell function and insulin sensitivity. |
| Secondary | Rate of Pancreatic Exocrine Insufficiency | 12 months | Derived outcome based on fecal elastase-1 measurement |
| Secondary | Rate of Pancreatic Endocrine Insufficiency | 12 months | Derived endocrine functional status based on fasting glucose, HbA1c and mixed-meal tolerance test. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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