| Trial ID: | L7385 |
| Source ID: | NCT04088851
|
| Associated Drug: |
On Metformin
|
| Title: |
"Hepatic Substrate Flux Rates in Type 2 Diabetes"
|
| Acronym: |
IMPACT
|
| Status: |
ACTIVE_NOT_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: On Metformin|DRUG: Off Metformin
|
| Outcome Measures: |
Primary: Hepatic gluconeogenic flux (U-13C-lactate tracer) (mg/min), Hepatic gluconeogenic flux rates from lactate \[mg/min\] in humans with T2D w/wo metformin treatment will be measured by specific tracer metabolism and turnover of the substrates., 2 weeks|Hepatic gluconeogenic flux (glycerol tracer) (mg/min), Hepatic gluconeogenic flux rates from glycerol \[mg/min\] in humans with T2D w/wo metformin treatment will be measured by specific tracer metabolism and turnover of the substrates., 2 weeks | Secondary: Endogenous glucose production (mg/min/kg BW), Endogenous glucose production (mg/min/kg BW) in humans with T2D w/wo metformin treatment will be measured by specific tracer metabolism and turnover of the substrates., 2 weeks|Hepatic mitochondrial oxidative flux (mg/min), Hepatic mitochondrial oxidative flux (mg/min) in humans with T2D w/wo metformin treatment will be measured by specific tracer metabolism and turnover of the substrates., 2 weeks|Hepatic gammaATP (mmol/L), Hepatic energy \[ATP mmol/l\] content will be assessed in people with T2D with and without metformin treatment by employing specific 31P- magnetic resonance spectroscopy., 2 weeks|Hepatic lipid content (%), Hepatic fat \[%\] content will be assessed in people with T2D with and without metformin treatment by employing specific 1H- magnetic resonance spectroscopy., 2 weeks
|
| Sponsor/Collaborators: |
Sponsor: German Diabetes Center | Collaborators: Yale University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
23
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2019-09-11
|
| Completion Date: |
2025-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2025-01-13
|
| Locations: |
German Diabetes Center, Duesseldorf, NRW, 40225, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT04088851
|
