Mechanisms of Fasting-Induced Insulin Resistance
NCT07928297, Not applicable, Not yet recruiting, German Diabetes Center
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Mechanisms of Fasting-Induced Insulin Resistance | ClinicalTrials.gov |
| NCT number | NCT07928297 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 18 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | German Diabetes Center | ClinicalTrials.gov |
| Conditions | Insulin Resistance, Fasting-Induced Insulin Resistance | ClinicalTrials.gov |
| Interventions | 60-hour Fasting, 12-hour Overnight Fasting (control) | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Skeletal muscle plasma membrane sn-1,2-diacylglycerol content | At the end of each study condition in both crossover periods (washout of at least 4 weeks): Day 2 of the control condition, after a 12-hour overnight fast, and Day 4 of the fasting condition, after 60 hours of fasting. | Difference in plasma membrane-associated sn-1,2-diacylglycerol (DAG) stereoisomer content in skeletal muscle between the 60-hour fasting condition and the control condition, assessed in basal vastus lateralis muscle biopsies. | ClinicalTrials.gov |
| Secondary | Skeletal muscle DAG content in mitochondrial/endoplasmic reticulum and cytosolic fractions | At the end of each study condition in both crossover periods (washout of at least 4 weeks): Day 2 of the control condition, after a 12-hour overnight fast, and Day 4 of the fasting condition, after 60 hours of fasting. | Difference in sn-1,2-diacylglycerol content in mitochondrial/endoplasmic reticulum and cytosolic fractions of basal skeletal muscle biopsies between fasting and control conditions | ClinicalTrials.gov |
| Secondary | Skeletal muscle PKC translocation | At the end of each study condition in both crossover periods (washout of at least 4 weeks): Day 2 of the control condition, after a 12-hour overnight fast, and Day 4 of the fasting condition, after 60 hours of fasting. | Difference in PKCθ, PKCε and PKCζ translocation, assessed as membrane-to-cytosol ratios in basal skeletal muscle biopsies between conditions | ClinicalTrials.gov |
| Secondary | Skeletal muscle insulin signalling phosphorylation | At the end of each study condition in both crossover periods (washout of at least 4 weeks): Day 2 of the control condition, after a 12-hour overnight fast, and Day 4 of the fasting condition, after 60 hours of fasting. | Difference in basal and insulin-stimulated phosphorylation of insulin receptor (Tyr1162/1163), IRS-1 (Tyr612, Ser307, Ser1101), Akt (Ser473, Thr308), TBC1D4 (Thr642), GSK3β (Ser9) and S6K1 (Thr389) between conditions | ClinicalTrials.gov |
| Secondary | Skeletal muscle ceramide content and ratio | At the end of each study condition in both crossover periods (washout of at least 4 weeks): Day 2 of the control condition, after a 12-hour overnight fast, and Day 4 of the fasting condition, after 60 hours of fasting. | Difference in skeletal muscle ceramide content and ceramide ratios between fasting and control conditions | ClinicalTrials.gov |
| Secondary | Whole-body insulin sensitivity | At the end of each study condition in both crossover periods (washout of at least 4 weeks): Day 2 of the control condition, after a 12-hour overnight fast, and Day 4 of the fasting condition, after 60 hours of fasting. | Difference in whole-body insulin sensitivity, expressed as M/I (glucose infusion rate corrected for changes in the glucose pool, divided by steady-state plasma insulin), during the last 30 minutes of the high-dose insulin step of the two-step hyperinsulinemic-euglycemic clamp, between fasting and control conditions. | ClinicalTrials.gov |
| Secondary | Insulin-induced suppression of endogenous glucose production | At the end of each study condition in both crossover periods (washout of at least 4 weeks): Day 2 of the control condition, after a 12-hour overnight fast, and Day 4 of the fasting condition, after 60 hours of fasting. | Difference in percentage suppression of EGP during the low-dose insulin step of the clamp, relative to basal EGP, between fasting and control conditions. | ClinicalTrials.gov |
| Secondary | Insulin-induced suppression of plasma NEFA | At the end of each study condition in both crossover periods (washout of at least 4 weeks): Day 2 of the control condition, after a 12-hour overnight fast, and Day 4 of the fasting condition, after 60 hours of fasting. | Difference in percentage suppression of plasma non-esterified fatty acids (NEFA) during the low-dose insulin step of the clamp, relative to basal NEFA, between fasting and control conditions. | ClinicalTrials.gov |
| Secondary | Insulin clearance | At the end of each study condition in both crossover periods (washout of at least 4 weeks): Day 2 of the control condition, after a 12-hour overnight fast, and Day 4 of the fasting condition, after 60 hours of fasting. | Difference in insulin clearance, calculated as insulin infusion rate divided by the steady-state increment in plasma insulin above baseline during the clamp, between fasting and control conditions. | ClinicalTrials.gov |
| Secondary | Skeletal muscle intramyocellular lipid content | On the day before the clamp in each study condition, in both crossover periods: Day 1 of the control condition, and Day 3 of the fasting condition, after approximately 42 hours of fasting. | Difference in intramyocellular lipid (IMCL) content in the tibialis anterior muscle, assessed by ¹H-magnetic resonance spectroscopy, between fasting and control conditions. | ClinicalTrials.gov |
| Secondary | Hepatic ATP concentration | On the clamp day of each study condition, before the start of insulin infusion, in both crossover periods: Day 2 of the control condition, after a 12-hour overnight fast, and Day 4 of the fasting condition, after 60 hours of fasting. | Difference in absolute hepatic γ-ATP concentration, assessed by ³¹P-magnetic resonance spectroscopy, between fasting and control conditions. | ClinicalTrials.gov |
| Secondary | Adipose tissue transcriptomics | At the end of each study condition in both crossover periods (washout of at least 4 weeks): Day 2 of the control condition, after a 12-hour overnight fast, and Day 4 of the fasting condition, after 60 hours of fasting. | Differences in adipose tissue gene expression profiles, assessed by transcriptomic analysis of subcutaneous abdominal adipose tissue biopsies, between fasting and control conditions. | ClinicalTrials.gov |
| Secondary | Adipose tissue-derived extracellular vesicle lipid content | At the end of each study condition in both crossover periods (washout of at least 4 weeks): Day 2 of the control condition, after a 12-hour overnight fast, and Day 4 of the fasting condition, after 60 hours of fasting. | Difference in diacylglycerol and ceramide content of extracellular vesicles isolated from subcutaneous abdominal adipose tissue biopsies, assessed by lipidomic profiling, between fasting and control conditions. | ClinicalTrials.gov |
| Other | Sex-by-condition interaction for skeletal muscle plasma membrane DAG content | At the end of each study condition in both crossover periods (washout of at least 4 weeks): Day 2 of the control condition, after a 12-hour overnight fast, and Day 4 of the fasting condition, after 60 hours of fasting. | Exploratory comparison of the fasting-induced change in plasma membrane sn-1,2-DAG content between men and women (sex-by-condition interaction), reported with effect sizes and confidence intervals. | ClinicalTrials.gov |
| Other | Sex-by-condition interaction for whole-body insulin sensitivity | At the end of each study condition in both crossover periods (washout of at least 4 weeks): Day 2 of the control condition, after a 12-hour overnight fast, and Day 4 of the fasting condition, after 60 hours of fasting. | Exploratory comparison of the fasting-induced change in M/I between men and women (sex-by-condition interaction), reported with effect sizes and confidence intervals. | ClinicalTrials.gov |
| Other | Sex-by-condition interaction for suppression of endogenous glucose production | At the end of each study condition in both crossover periods (washout of at least 4 weeks): Day 2 of the control condition, after a 12-hour overnight fast, and Day 4 of the fasting condition, after 60 hours of fasting. | Exploratory comparison of the fasting-induced change in percentage EGP suppression during the low-dose insulin step between men and women (sex-by-condition interaction), reported with effect sizes and confidence intervals. | 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)