Trial · NCT06068803
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in 24hr average glucose area under the curve (AUC) | 1 day during baseline period and 1 day during the intervention period | Glucose control will be measured using a continuous glucose monitoring device worn throughout the baseline period and weeks 3 and 4 of the intervention period. Change in 24h average glucose AUC will be assessed on 'matched meal and activity days' i.e. days during intervention and baseline that are matched for food intake and physical activity. |
| Secondary | Change in glycemic variability | 1 day during baseline period and 1 day during the intervention period | Glucose control will be measured using continuous glucose monitoring device worn throughout the baseline period and weeks 3 and 4 of the intervention period. Change in glycemic variability will be assessed on 'matched meal and activity days' i.e. days during intervention and baseline that are matched for food intake and physical activity. |
| Secondary | Change in serum fructosamine | Pre (day 0) and post (day 29) | Measured in fasting blood sample by automated analyser (Daytona Rx) |
| Secondary | Change in fasting plasma glucose | Pre (day 0) and post (day 29) | Measured in fasting blood sample by automated analyser (Daytona Rx) |
| Secondary | Change in fasting lipid profile concentrations | Pre (day 0) and post (day 29) | Measured in fasting blood sample by automated analyser (Daytona Rx) |
| Secondary | Change in fasting plasma free fatty acids (FFA) | Pre (day 0) and post (day 29) | Measured in fasting blood sample by automated analyser (Daytona Rx) |
| Secondary | Change in fasting plasma insulin | Pre (day 0) and post (day 29) | Measured in fasting blood sample using a high-sensitivity human insulin enzyme-like immunosorbent assay (ELISA) |
| Secondary | Change in Insulin Sensitivity Index | Pre (day 0) and post (day 29) | Calculated from fasting plasma insulin and fasting plasma glucose |
| Secondary | Change in Adipose tissue Insulin Resistance index (Adipo-IR) | Pre (day 0) and post (day 29) | Calculated from fasting plasma insulin and fasting plasma FFA |
| Secondary | Change in body mass | Pre (day 0) and post (day 29) | Measured using a digital body weight scales |
| Secondary | Change in waist and hip circumference | Pre (day 0) and post (day 29) | Measured using a measurement tape |
| Secondary | Change in waist to hip ratio | Pre (day 0) and post (day 29) | Calculated from waist and hip circumferences |
| Secondary | Change in fat mass and fat free mass | Pre (day 0) and post (day 29) | Assessed by Dual Energy X-ray Absorptiometry (DEXA) scan |
| Secondary | Change in calf muscle density, quality and area | Pre (day 0) and post (day 29) | Assessed by calf peripheral Quantitative Computed Tomography (pQCT) |
| Secondary | Change in blood pressure | Pre (day 0) and post (day 29) | Measured using an automated blood pressure device. Both systolic and diastolic blood pressure will be measured |
| Secondary | Change in circulating adipokines and inflammatory cytokines | Pre (day 0) and post (day 29) | Key inflammatory cytokines including CRP will be quantified by R-plex, U-plex and V-plex kits on a Mesoscale QuickPlex SQ120 |
| Secondary | Change in blood immune cell phenotype, function and activation | Pre (day 0) and post (day 29) | Peripheral blood mononuclear cells (PBMCs) isolated from whole blood will be incubated with fluorophore-conjugated antibodies and analysed with a flow cytometer to examine the phenotype and cytokine production of immune cells |
| Secondary | Change in adipose tissue immune cell phenotype, function and activation | Pre (day 0) and post (day 29) | Adipose tissue stromal vascular fraction (SVF) will be incubated with fluorophore-conjugated antibodies and analysed with a flow cytometer to examine the phenotype and cytokine production of immune cells |
| Secondary | Change adipose tissue adipokine and cytokine concentrations | Pre (day 0) and post (day 29) | Adipose tissue explants will be cultured ex vivo for 3h. Concentrations of key adipokines and cytokines in supernatant will be quantified by R-plex, U-plex and V-plex kits on a Mesoscale QuickPlex SQ120 |
| Secondary | Change in adipose tissue gene expression | Pre (day 0) and post (day 29) | Whole-tissue RNAseq |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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.
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