Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
NCT07921940, Not applicable, Active not recruiting, Medical University of Vienna
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy | ClinicalTrials.gov |
| NCT number | NCT07921940 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 40 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Medical University of Vienna | ClinicalTrials.gov |
| Conditions | Obesity & Overweight, Gestational Diabetes Mellitus (GDM), Insulin Resistance, Maternal Obesity Complicating Pregnancy | ClinicalTrials.gov |
| Interventions | OMNi-BiOTiC® METAtox | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Insulin sensitivity assessed by the PREDIM index | 12+0 to 15+6 (V1) and 24+0 to 27+6 (V2) weeks of gestation | Insulin sensitivity will be assessed by the Predicted M index (PREDIM), derived from a 2-h 75g oral glucose tolerance test and compared between groups. | ClinicalTrials.gov |
| Secondary | Further insulin sensitivity and insulin resistance indices | 12+0 to 15+6 (V1) and 24+0 to 27+6 (V2) weeks of gestation | Insulin sensitivity and insulin resistance indices (OGIS, Matsuda Index, HOMA-IR, QUICKI) derived from a 2-h 75g oral glucose tolerance test and compared between groups. | ClinicalTrials.gov |
| Secondary | Insulin secretion and beta-cell function indices | 12+0 to 15+6 (V1) and 24+0 to 27+6 (V2) weeks of gestation | Insulin secretion and beta-cell function indices (insulinogenic index, oral disposition index) derived from a 2-h 75g oral glucose tolerance test and compared between groups. | ClinicalTrials.gov |
| Secondary | Glycemic profile assessed by continuous glucose monitoring | 12+0 to 15+6 (V1), 24+0 to 27+6 (V2) and 35+0 to 37+6 (V3) weeks of gestation | Mean glucose and percentage of time in range (63-140mg/dL), above, range and below range over 10 days continuous glucose monitoring | ClinicalTrials.gov |
| Secondary | Fetal growth parameters assessed by ultrasound | 24+0 to 27+6 (V2) and 35+0 to 37+6 (V3) weeks of gestation | Head circumference, biparietal diameter, abdominal circumference, abdominal fat thickness, femur length, and estimated fetal weight, expressed as absolute values and gestational age-specific percentiles. | ClinicalTrials.gov |
| Secondary | Umbilical cord blood glucose | At delivery | Glucose concentration (mg/dL) in umbilical cord blood. | ClinicalTrials.gov |
| Secondary | Umbilical cord blood insulin | At delivery. | Insulin concentration (µU/ml) in umbilical cord blood. | ClinicalTrials.gov |
| Secondary | Umbilical cord blood C-peptide | At delivery. | C-peptide concentration (ng/ml) in umbilical cord blood. | ClinicalTrials.gov |
| Secondary | Umbilical cord blood pH | At delivery. | Arterial umbilical cord blood pH. | ClinicalTrials.gov |
| Secondary | Umbilical cord blood base excess | At delivery. | Arterial umbilical cord blood base excess (mmol/L). | ClinicalTrials.gov |
| Secondary | Birth weigth percentile and proportion of large- and small-for-gestational-age newborns | At delivery | Sex- and gestational age-adjusted birth weight percentile, large for gestational age defined as \>90th percentile, small for gestational age as \<10th percentile | ClinicalTrials.gov |
| Secondary | Obstetric and neonatal outcomes | From delivery up to 48 hours postpartum | Mode of delivery, APGAR score, shoulder dystocia, neonatal hypoglycemia, admission to neonatal intensive care unit | ClinicalTrials.gov |
| Secondary | Maternal and neonatal gut microbiome composition | Maternal: 12+0 to 15+6 (V1), 24+0 to 27+6 (V2) and 35+0 to 37+6 (V3) weeks of gestation Neonatal: first stool after birth | Bacterial and fungal composition of maternal stool and neonatal meconiumassessed by 16S rRNA and ITS amplicon sequencing | ClinicalTrials.gov |
| Other | Maternal fasting triglycerides | 12+0 to 15+6 (V1), 24+0 to 27+6 (V2) and 35+0 to 37+6 (V3) weeks of gestation | Fasting serum triglyceride concentration (mg/dL). | ClinicalTrials.gov |
| Other | Maternal fasting total cholesterol | 12+0 to 15+6 (V1), 24+0 to 27+6 (V2) and 35+0 to 37+6 (V3) weeks of gestation | Fasting serum total cholesterol concentration (mg/dL). | ClinicalTrials.gov |
| Other | Maternal fasting LDL cholesterol | 12+0 to 15+6 (V1), 24+0 to 27+6 (V2) and 35+0 to 37+6 (V3) weeks of gestation | Fasting serum LDL cholesterol concentration (mg/dL). | ClinicalTrials.gov |
| Other | Maternal fasting HDL cholesterol | 12+0 to 15+6 (V1), 24+0 to 27+6 (V2) and 35+0 to 37+6 (V3) weeks of gestation | Fasting serum HDL cholesterol concentration (mg/dL). | ClinicalTrials.gov |
| Other | Maternal HbA1c | 12+0 to 15+6 (V1), 24+0 to 27+6 (V2) and 35+0 to 37+6 (V3) weeks of gestation | Glycated haemoglobin (HbA1c, %) | ClinicalTrials.gov |
| Other | Dietary quality assessed by a validated food frequency questionnaire | 12+0 to 15+6 (V1), 24+0 to 27+6 (V2) and 35+0 to 37+6 (V3) weeks of gestation | Diet quality assessed by a food frequency questionnaire (FFQ, Robert Koch Institute) and summarized as a modified Alternate Healthy Eating Index 2010 (AHEI-2010) adapted for pregnancy. Score range 0 to maximum, higher scores indicate better diet quality. | ClinicalTrials.gov |
| Other | Physical activity assessed by the International Physical Activity Questionnaire (IPAQ) | 12+0 to 15+6 (V1), 24+0 to 27+6 (V2) and 35+0 to 37+6 (V3) weeks of gestation | Total physical activity assessed by the IPAQ long form, expressed as metabolic equivalent of task (MET) minutes per week. Higher values indicate more physical activity. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)