Trial · NCT07884058
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Effect of IGOB131 on postprandial GLP-1 response (0-180 minutes) | 16 weeks | Postprandial GLP-1 responses will be assessed at baseline and week 16 following ingestion of a standardized test meal. Blood samples will be collected at 0 (fasting), 30, 60, 90, 120, 150, and 180 minutes post-meal. |
| Primary | Effect of IGOB131 on fasting plasma GLP-1 concentrations | 16 weeks | Blood samples will be collected at 0 (fasting), 30, 60, 90, 120, 150, and 180 minutes post-meal. Plasma GLP-1 concentrations will be measured using a validated enzyme-linked immunosorbent assay (ELISA). |
| Primary | Effect of IGOB131 on DPP-4 enzymatic activity | 16 weeks | Fasting venous blood samples will be collected at baseline and at weeks 4, 8, 12, and 16 following an overnight fast (≥10 hours). DPP-4 activity will be determined using a colorimetric assay based on enzymatic cleavage of a specific substrate. |
| Secondary | Effect of IGOB131 on fasting blood glucose | 16 weeks | Fasting venous blood samples will be collected at baseline and at weeks 4, 8, 12, and 16 following an overnight fast (≥10 hours). Fasting glucose will be measured using the glucose oxidase method. |
| Secondary | Effect of IGOB131 on fasting insulin | 16 weeks | Fasting venous blood samples will be collected at baseline and at weeks 4, 8, 12, and 16 following an overnight fast (≥10 hours). Fasting insulin concentrations will be measured by immunoassay. |
| Secondary | Effect of IGOB131 on glycated hemoglobin (HbA1c) | 16 weeks | Fasting venous blood samples will be collected at baseline and at weeks 4, 8, 12, and 16 following an overnight fast (≥10 hours). HbA1c will be measured by high-performance liquid chromatography (HPLC) |
| Secondary | Effect of IGOB131 on homeostatic model assessment for insulin resistance (HOMA-IR) | 16 weeks | Fasting venous blood samples will be collected at baseline and at weeks 4, 8, 12, and 16 following an overnight fast (≥10 hours). HOMA-IR will be calculated using the formula: HOMA-IR = (fasting insulin \[µIU/mL\] × fasting glucose \[mg/dL\]) / 405 |
| Secondary | Effect of IGOB131 on TNF-α | 16 weeks | Fasting venous blood samples will be collected at baseline and at weeks 4, 8, 12, and 16 following an overnight fast (≥10 hours). TNF-α will be quantified using high-sensitivity ELISA kits according to the manufacturer's protocols. |
| Secondary | Effect of IGOB131 on IL-6 | 16 weeks | Fasting venous blood samples will be collected at baseline and at weeks 4, 8, 12, and 16 following an overnight fast (≥10 hours). IL-6 will be quantified using high-sensitivity ELISA kits according to the manufacturer's protocols. |
| Secondary | Effect of IGOB131 on body weight | 16 weeks | Body weight will be measured using a calibrated digital scale with participants wearing light clothing and no shoes. Measurements will be performed in duplicate and averaged. |
| Secondary | Effect of IGOB131 on BMI | 16 weeks | Body mass index (BMI) will be calculated as body weight in kilograms divided by the square of height in metres (kg/m²). Height will be measured at baseline using a stadiometer, and body weight will be measured using a calibrated digital scale. Duplicate measurements will be averaged, as applicable. The outcome will be reported as BMI in kg/m². |
| Secondary | Effect of IGOB131 on body fat percentage | 16 weeks | Body fat percentage will be assessed using bioelectrical impedance analysis (BIA). Measurements will be performed in duplicate and averaged. |
| Secondary | Effect of IGOB131 on waist circumference | 16 weeks | Waist circumference will be measured at the midpoint between the lower rib margin and the iliac crest using a non-stretchable tape. Measurements will be performed in duplicate and averaged. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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.
For software
Read this list from software.
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