An interventional study of On Metformin and Off Metformin in Type 2 Diabetes, sponsored by German Diabetes Center. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by German Diabetes Center · Not applicable, Interventional, and Basic science
Investigation of the effects of redox shuttle inhibition by metformin on gluconeogenic flux rates of lactate and glycerol in humans with type 2 diabetes
Type 2 diabetes (T2D) is characterized by insulin resistance and relative insulin deficiency leading to hyperglycemia. Enhanced endogenous glucose production during fasting is a key feature of hepatic insulin resistance and a major contributor to deterioration of glycemia. Metformin reduces fasting gluconeogenesis (GNG); the underlying mechanisms are still not fully understood, but involve the inhibition of complexes of the electron transport chain and thus the redox shuttle.
The investigators have previously provided evidence for abnormal hepatic ATP synthesis and mitochondrial efficiency in T2D, but it remains unknown, how and which substrate fluxes account for excessive GNG in T2D. For this reason, this proposal aims at investigating hepatic glucose and energy fluxes in T2D with focus on gluconeogenic contribution of lactate and glycerol to hepatic mitochondrial substrate flux, mitochondrial ATP synthase flux and the activity of the redox shuttle, also after metformin intake, by using a novel combination of positional isotopomer nuclear magnetic resonance (NMR) analysis (PINTA) with multinuclei magnetic resonance spectroscopy (MRS).
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's planned enrollment of 23 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →German Diabetes Center is the lead sponsor of 27 studies on the registry; 6 are open to participants now.
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Exclusion criteria:
Participants with type-2 diabetes will intake metformin 1 g daily for 2 weeks
Drug: On Metformin
Participants with type-2 diabetes will pause metformin 1 g daily for 2 weeks
Drug: Off Metformin
Oral intake of Metformin (1 g / day) for 2 weeks
No oral intake of Metformin (1 g / day) for 2 weeks
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.
Time frame: 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.
Time frame: 2 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 weeks
Plan to share: No
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This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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German Diabetes Center