Type 2 DiabetesDIMITOSNCT02948673
The Production of Reactive Oxygen Species in Response to Glutathione Supplementation and Acute Exercise
A study testing Glutathione in people with Type 2 Diabetes and Oxidative Stress, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Objectives: The research focus of the study is the production of reactive oxygen species (ROS) in patients with type 2 diabetes (T2D) in response to glutathione (GSH) supplementation and in response to acute exercise. Read more about this study
- Who is it for?
- Ages 30 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Oxidative Stress, Mitochondrial Reactive Oxygen Species Production
- What is being tested?
- Glutathione
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- May 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- For patients with type 2 diabetes:
- Male
- 30-50 years
- BMI: 28-35
- ECG with no evidence of heart disease
- HbA1c > 6.5% (48mmol/mol)
Show all 11Show fewer
- For control subjects:
- Male
- 30-50 years
- BMI: 28-35
- ECG with no evidence of Heart disease
Who cannot join
- For patients with type 2 diabetes::
- Insulin treatment
- Antioxidant supplementation or other dietary supplements
- Cholesterol lowering medicine
- For control subjects:
- Antioxidant supplementation or other dietary supplements
- Cholesterol lowering medicine
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Xlab, Department of Biomedical Sciences, Faculty Of Health Sciences, University of Copenhagen
Copenhagen, Nørrebro, 2200
About this study
Official title: The Production of Reactive Oxygen Species in Response to Glutathione Supplementation and Acute Exercise in Patients With Type 2 Diabetes
Objectives: The research focus of the study is the production of reactive oxygen species (ROS) in patients with type 2 diabetes (T2D) in response to glutathione (GSH) supplementation and in response to acute exercise.
Oxidative stress is suggested as a possible causative factor in the pathophysiology of skeletal muscle insulin resistance. GSH is the most abundant endogenous antioxidant in the cell and thus, a crucial protector against oxidative stress and insulin resistance. It has been found that patients with T2D have a decreased level of GSH in plasma and that 1 h GSH infusion improves skeletal muscle glucose uptake by ~25% and the redox environment in patients with T2D. Therefore, we want to investigate the effect of 3 months of GSH supplementation on skeletal muscle insulin sensitivity and mitochondrial ROS production in patients with T2D and healthy controls.
Read more
Hypothesis: Oral GSH supplementation will improve skeletal muscle insulin sensitivity in patients with T2D and this effect will be linked to a reduced mitochondrial ROS production in the skeletal muscle.
In contrast to the link between oxidative stress and insulin resistance, ROS produced in response to exercise is an important physiological stimulus as it is suggested to play a key role in the beneficial mitochondrial biogenesis observed in response to training. It has been reported that some patients with T2D have a diminished mitochondrial biogenesis in response to training, but the reason for this defect is not known. We want to investigate the link between exercise-stimulated ROS production and the mitochondrial biogenesis response in patients with T2D and healthy controls in response to acute exercise at two different intensities.
Hypothesis: Considering the pathological condition of T2D skeletal muscle (i.e. high chronic ROS level), we speculate that a lower exercise intensity, leading to a lower exercise-stimulated ROS production is a more optimal stimulus (i.e. not to high) for mitochondrial biogenesis in patients with T2D.
Read the detailed description
ROS production in response to glutathione supplementation:
Today, 387 million people worldwide suffer from T2D and this number is expected to increase to 592 million in 2035. Skeletal muscle is responsible for ~75% of the total glucose uptake, making skeletal muscle the quantitatively most important tissue when it comes to insulin resistance (1). It has been suggested that oxidative stress may represent a possible causative factor in the pathophysiology of skeletal muscle insulin resistance. The link between ROS and skeletal muscle insulin resistance has been established both in vitro and in vivo (2, 3), but few studies have actually measured ROS production in skeletal muscle of T2D patients (4-6). Mitochondria are a source of ROS, and also a major target of oxidative damage (7). The mitochondrial defense system against oxidative stress relies on endogenous antioxidants. Glutathione (GSH) is the most abundant endogenous antioxidant in the cell and thus, a crucial protector against oxidative stress and insulin resistance (8). Supporting this, patients with T2D have a decreased level of GSH and an increased level of oxidized GSH (GSSG) in plasma (9) and insulin resistant subjects are reported to have an increased mitochondrial ROS production as well as a reduced GSH/GSSG ratio in skeletal muscle compared to healthy controls (3). In addition, 1 h glutathione infusion has been found to increase glucose uptake in patients with T2D by ~25% and to improve the redox environment, as reflected by an increased GSH/GSSG ratio in plasma; effects that were not seen in the healthy controls (10). The effect of prolonged oral GSH supplementation on skeletal muscle insulin sensitivity and mitochondrial ROS production in patients with T2D has, to our knowledge, never been investigated.
Research questions 1: Does oral GSH supplementation improve skeletal muscle insulin sensitivity in patients with T2D and healthy controls? And if so, can this effect be linked to a more beneficial redox state in the muscle cell? Hypothesis: Oral GSH supplementation will improve skeletal muscle insulin sensitivity in patients with T2D and this effect will be linked to a reduced mitochondrial ROS production in the skeletal muscle.
ROS production in response to acute exercise:
Acute exercise induces a marked increase in the transcription of peroxisome proliferator-activated receptor-γ coactivator-1α (PGC-1α) (11), and therefore, PGC-1α is believed to play a key role in training-induced mitochondrial biogenesis (12). Contraction of rat skeletal muscle cells increases ROS production and PGC-1α mRNA expression, but in the presence of antioxidants, ROS production is reduced and the increase in PGC-1α mRNA is abolished (13). Also, exercise combined with allopurinol (an inhibitor of ROS production) severely attenuates the magnitude of the exercise-induced increased PGC-1α mRNA in rats, compared to exercise alone (14). These findings suggest that PGC-1α, at least in part, is regulated through a mechanism that involves ROS. Furthermore, it has been suggested that ROS regulates PGC-1α via activation of AMP-activated protein kinase (AMPK) (15). Interestingly, subjects with insulin resistance have a decreased exercise-stimulated AMPK activity, compared to lean controls (16, 17), which might explain the attenuated training-induced mitochondrial biogenesis observed in some patients with T2D (5, 17, 18), but not all (19). Whether ROS production is implicated in an abnormal training response is not known. Our current knowledge of ROS in response to acute exercise is derived from studies in animals and cells, and no study has, to our knowledge, investigated the link between ROS and mitochondrial biogenesis in patients with T2D in response to acute exercise.
Research questions 2: Does the exercise-induced increased ROS production required for a mitochondrial biogenesis response differ between patients with T2D and healthy controls? If so, does low intensity exercise reduce the transient ROS production and thus, result in a higher mitochondrial biogenesis response in patients with T2D, compared to exercise at high intensity? Hypothesis: Considering the pathological condition of T2D skeletal muscle (i.e. high chronic ROS level), it is hypothesized that a lower exercise intensity, leading to a lower exercise-stimulated ROS production is a more optimal stimulus (i.e. not to high) for mitochondrial biogenesis in patients with T2D.
Material and methodology:
20 patients with T2D (non-insulin dependent) and 20 healthy controls will be recruited to the study. The two groups will be matched on age, weight and maximal oxygen consumption (VO2 max).
Approach for the study: The study is a double blinded randomized placebo controlled trial.
At each attendance to the laboratory (except for the day of screening), the subjects are asked to:
- Report to the laboratory in an overnight fasted state
- Abstain from alcohol and physical activity 24 hours prior to each study day.
- Repeat the same diet as the enclosed 24-hour recall questionnaire prescribes (the subjects are also asked to complete a 24-hour dietary recall questionnaire on their first attendance to the laboratory)
Screening: Before the subjects are included in the study, a standard clinical examination will be conducted, including medical history, glycated hemoglobin (HbA1c) and ECG.
If included in the study, the subjects undergoes 3 experimental days before and after the intervention.
Test day 1:
- Dual Energy X-ray Absorptiometry-scan to measure body composition,
- Incremental exercise test to determine the exercise intensity that elicits maximal fat oxidation (Fatmax test)
- Incremental exercise test to exhaustion to determine VO2 max.
Test day 2:
- Muscle biopsies from vastus lateralis (basal, immediately after exercise cessation and after 90 min of recovery)
- Acute exercise tests on bicycle ergometers at 70% of VO2 max (moderate intensity) or at 50% of VO2 max (low intensity). The two exercise tests will be matched for total amount of work (kJ). 10 subjects with T2D and 10 control subjects are randomized to each exercise test.
Test day 3:
- Measurement of resting metabolic rate by canopy hood (basal and during the clamp)
- Intravenous glucose tolerance test
- Hyperinsulinaemic euglycaemic clamp
After the experimental days, the subjects are randomized into placebo or GSH supplementation and instructed to consume either 1000 mg GSH/day or placebo daily (2 tablets in the morning and 2 tablets in the evening) for 4 weeks.
Statistical considerations:
The comparison of the groups or the interventions will be performed using a one-way or a two-way ANOVA test with repeated measures, as appropriate. Based on the variation shown in previous studies an expected 80% power and a significance level of P<0.05, power calculations have shown that 12 subjects in each group is sufficient in regards to mitochondrial functionality measurements and insulin sensitivity. Data from a previous study investigating GSH in healthy subjects indicates that 15 subjects are needed in order to find a difference in this parameter (3).
- Being tested
- Glutathione, Placebo
- Keywords
- type 2 diabetes, mitochondrial reactive oxygen species production, oxidative stress, antioxidant treatment, glutathione supplementation
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutathioneDietary supplement
Also called Setria Glutathion
4 oral GSH tablets/day (1000mg/day) for 4 weeks
PlaceboOther
4 oral placebo tablets for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 4 placebo tablets/day (2 in the morning and 2 in the evening) Receives: Other: Placebo |
| Glutathione | Active comparator | 4 oral GSH tablets/day (2 in the morning and 2 in the evening) Receives: Dietary Supplement: Glutathione |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Difference in insulin sensitivity (measured as glucose infusion rate during a hyperinsulinaemic euglycaemic clamp) between patients with type 2 diabetes receiving glutathione supplementation and patients with type 2 diabetes receiving placebo.
Measured: 12 weeks
Secondary outcomes (1)
Mitochondrial reactive oxygen species production
Difference in the mitochondrial reactive oxygen species production between patients with type 2 diabetes receiving glutathione supplementation and patients with type 2 diabetes receiving placebo.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steen Larsen, University of Copenhagen
- Investigators
- Steen Larsen, Ass. prof., Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948673
- Sponsor's protocol ID
- DIMITOS
- Acronym
- DIMITOS
- Status last verified
- May 2018
- First submitted
- 26 Oct 2016
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
DeFronzo RA. Lilly lecture 1987. The triumvirate: beta-cell, muscle, liver. A collusion responsible for NIDDM. Diabetes. 1988 Jun;37(6):667-87. doi: 10.2337/diab.37.6.667. No abstract available.
PubMed 3289989Houstis N, Rosen ED, Lander ES. Reactive oxygen species have a causal role in multiple forms of insulin resistance. Nature. 2006 Apr 13;440(7086):944-8. doi: 10.1038/nature04634.
PubMed 16612386Anderson EJ, Lustig ME, Boyle KE, Woodlief TL, Kane DA, Lin CT, Price JW 3rd, Kang L, Rabinovitch PS, Szeto HH, Houmard JA, Cortright RN, Wasserman DH, Neufer PD. Mitochondrial H2O2 emission and cellular redox state link excess fat intake to insulin resistance in both rodents and humans. J Clin Invest. 2009 Mar;119(3):573-81. doi: 10.1172/JCI37048. Epub 2009 Feb 2.
PubMed 19188683Abdul-Ghani MA, Jani R, Chavez A, Molina-Carrion M, Tripathy D, Defronzo RA. Mitochondrial reactive oxygen species generation in obese non-diabetic and type 2 diabetic participants. Diabetologia. 2009 Apr;52(4):574-82. doi: 10.1007/s00125-009-1264-4. Epub 2009 Jan 30.
PubMed 19183935Hey-Mogensen M, Hojlund K, Vind BF, Wang L, Dela F, Beck-Nielsen H, Fernstrom M, Sahlin K. Effect of physical training on mitochondrial respiration and reactive oxygen species release in skeletal muscle in patients with obesity and type 2 diabetes. Diabetologia. 2010 Sep;53(9):1976-85. doi: 10.1007/s00125-010-1813-x. Epub 2010 Jun 6.
PubMed 20526759Chanseaume E, Barquissau V, Salles J, Aucouturier J, Patrac V, Giraudet C, Gryson C, Duche P, Boirie Y, Chardigny JM, Morio B. Muscle mitochondrial oxidative phosphorylation activity, but not content, is altered with abdominal obesity in sedentary men: synergism with changes in insulin sensitivity. J Clin Endocrinol Metab. 2010 Jun;95(6):2948-56. doi: 10.1210/jc.2009-1938. Epub 2010 Apr 9.
PubMed 20382691Murphy MP. How mitochondria produce reactive oxygen species. Biochem J. 2009 Jan 1;417(1):1-13. doi: 10.1042/BJ20081386.
PubMed 19061483Richie JP Jr, Nichenametla S, Neidig W, Calcagnotto A, Haley JS, Schell TD, Muscat JE. Randomized controlled trial of oral glutathione supplementation on body stores of glutathione. Eur J Nutr. 2015 Mar;54(2):251-63. doi: 10.1007/s00394-014-0706-z. Epub 2014 May 5.
PubMed 24791752Calabrese V, Cornelius C, Leso V, Trovato-Salinaro A, Ventimiglia B, Cavallaro M, Scuto M, Rizza S, Zanoli L, Neri S, Castellino P. Oxidative stress, glutathione status, sirtuin and cellular stress response in type 2 diabetes. Biochim Biophys Acta. 2012 May;1822(5):729-36. doi: 10.1016/j.bbadis.2011.12.003. Epub 2011 Dec 11.
PubMed 22186191De Mattia G, Bravi MC, Laurenti O, Cassone-Faldetta M, Armiento A, Ferri C, Balsano F. Influence of reduced glutathione infusion on glucose metabolism in patients with non-insulin-dependent diabetes mellitus. Metabolism. 1998 Aug;47(8):993-7. doi: 10.1016/s0026-0495(98)90357-2.
PubMed 9711998Pilegaard H, Saltin B, Neufer PD. Exercise induces transient transcriptional activation of the PGC-1alpha gene in human skeletal muscle. J Physiol. 2003 Feb 1;546(Pt 3):851-8. doi: 10.1113/jphysiol.2002.034850.
PubMed 12563009Hood DA. Invited Review: contractile activity-induced mitochondrial biogenesis in skeletal muscle. J Appl Physiol (1985). 2001 Mar;90(3):1137-57. doi: 10.1152/jappl.2001.90.3.1137.
PubMed 11181630Silveira LR, Pilegaard H, Kusuhara K, Curi R, Hellsten Y. The contraction induced increase in gene expression of peroxisome proliferator-activated receptor (PPAR)-gamma coactivator 1alpha (PGC-1alpha), mitochondrial uncoupling protein 3 (UCP3) and hexokinase II (HKII) in primary rat skeletal muscle cells is dependent on reactive oxygen species. Biochim Biophys Acta. 2006 Sep;1763(9):969-76. doi: 10.1016/j.bbamcr.2006.06.010. Epub 2006 Jul 7.
PubMed 16916551Kang C, O'Moore KM, Dickman JR, Ji LL. Exercise activation of muscle peroxisome proliferator-activated receptor-gamma coactivator-1alpha signaling is redox sensitive. Free Radic Biol Med. 2009 Nov 15;47(10):1394-400. doi: 10.1016/j.freeradbiomed.2009.08.007. Epub 2009 Aug 14.
PubMed 19686839Irrcher I, Ljubicic V, Hood DA. Interactions between ROS and AMP kinase activity in the regulation of PGC-1alpha transcription in skeletal muscle cells. Am J Physiol Cell Physiol. 2009 Jan;296(1):C116-23. doi: 10.1152/ajpcell.00267.2007. Epub 2008 Nov 12.
PubMed 19005163
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Production of Reactive Oxygen Species in Response to Glutathione Supplementation and Acute Exercise in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02948673
- Acronym / sponsor ID
- DIMITOS / DIMITOS
- Keywords
- type 2 diabetes, mitochondrial reactive oxygen species production, oxidative stress, antioxidant treatment, glutathione supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: The research focus of the study is the production of reactive oxygen species (ROS) in patients with type 2 diabetes (T2D) in response to glutathione (GSH) supplementation and in response to acute exercise.
Oxidative stress is suggested as a possible causative factor in the pathophysiology of skeletal muscle insulin resistance. GSH is the most abundant endogenous antioxidant in the cell and thus, a crucial protector against oxidative stress and insulin resistance. It has been found that patients with T2D have a decreased level of GSH in plasma and that 1 h GSH infusion improves skeletal muscle glucose uptake by ~25% and the redox environment in patients with T2D. Therefore, we want to investigate the effect of 3 months of GSH supplementation on skeletal muscle insulin sensitivity and mitochondrial ROS production in patients with T2D and healthy controls.
Hypothesis: Oral GSH supplementation will improve skeletal muscle insulin sensitivity in patients with T2D and this effect will be linked to a reduced mitochondrial ROS production in the skeletal muscle.
In contrast to the link between oxidative stress and insulin resistance, ROS produced in response to exercise is an important physiological stimulus as it is suggested to play a key role in the beneficial mitochondrial biogenesis observed in response to training. It has been reported that some patients with T2D have a diminished mitochondrial biogenesis in response to training, but the reason for this defect is not known. We want to investigate the link between exercise-stimulated ROS production and the mitochondrial biogenesis response in patients with T2D and healthy controls in response to acute exercise at two different intensities.
Hypothesis: Considering the pathological condition of T2D skeletal muscle (i.e. high chronic ROS level), we speculate that a lower exercise intensity, leading to a lower exercise-stimulated ROS production is a more optimal stimulus (i.e. not to high) for mitochondrial biogenesis in patients with T2D.
Detailed description
ROS production in response to glutathione supplementation:
Today, 387 million people worldwide suffer from T2D and this number is expected to increase to 592 million in 2035. Skeletal muscle is responsible for ~75% of the total glucose uptake, making skeletal muscle the quantitatively most important tissue when it comes to insulin resistance (1). It has been suggested that oxidative stress may represent a possible causative factor in the pathophysiology of skeletal muscle insulin resistance. The link between ROS and skeletal muscle insulin resistance has been established both in vitro and in vivo (2, 3), but few studies have actually measured ROS production in skeletal muscle of T2D patients (4-6). Mitochondria are a source of ROS, and also a major target of oxidative damage (7). The mitochondrial defense system against oxidative stress relies on endogenous antioxidants. Glutathione (GSH) is the most abundant endogenous antioxidant in the cell and thus, a crucial protector against oxidative stress and insulin resistance (8). Supporting this, patients with T2D have a decreased level of GSH and an increased level of oxidized GSH (GSSG) in plasma (9) and insulin resistant subjects are reported to have an increased mitochondrial ROS production as well as a reduced GSH/GSSG ratio in skeletal muscle compared to healthy controls (3). In addition, 1 h glutathione infusion has been found to increase glucose uptake in patients with T2D by ~25% and to improve the redox environment, as reflected by an increased GSH/GSSG ratio in plasma; effects that were not seen in the healthy controls (10). The effect of prolonged oral GSH supplementation on skeletal muscle insulin sensitivity and mitochondrial ROS production in patients with T2D has, to our knowledge, never been investigated.
Research questions 1: Does oral GSH supplementation improve skeletal muscle insulin sensitivity in patients with T2D and healthy controls? And if so, can this effect be linked to a more beneficial redox state in the muscle cell? Hypothesis: Oral GSH supplementation will improve skeletal muscle insulin sensitivity in patients with T2D and this effect will be linked to a reduced mitochondrial ROS production in the skeletal muscle.
ROS production in response to acute exercise:
Acute exercise induces a marked increase in the transcription of peroxisome proliferator-activated receptor-γ coactivator-1α (PGC-1α) (11), and therefore, PGC-1α is believed to play a key role in training-induced mitochondrial biogenesis (12). Contraction of rat skeletal muscle cells increases ROS production and PGC-1α mRNA expression, but in the presence of antioxidants, ROS production is reduced and the increase in PGC-1α mRNA is abolished (13). Also, exercise combined with allopurinol (an inhibitor of ROS production) severely attenuates the magnitude of the exercise-induced increased PGC-1α mRNA in rats, compared to exercise alone (14). These findings suggest that PGC-1α, at least in part, is regulated through a mechanism that involves ROS. Furthermore, it has been suggested that ROS regulates PGC-1α via activation of AMP-activated protein kinase (AMPK) (15). Interestingly, subjects with insulin resistance have a decreased exercise-stimulated AMPK activity, compared to lean controls (16, 17), which might explain the attenuated training-induced mitochondrial biogenesis observed in some patients with T2D (5, 17, 18), but not all (19). Whether ROS production is implicated in an abnormal training response is not known. Our current knowledge of ROS in response to acute exercise is derived from studies in animals and cells, and no study has, to our knowledge, investigated the link between ROS and mitochondrial biogenesis in patients with T2D in response to acute exercise.
Research questions 2: Does the exercise-induced increased ROS production required for a mitochondrial biogenesis response differ between patients with T2D and healthy controls? If so, does low intensity exercise reduce the transient ROS production and thus, result in a higher mitochondrial biogenesis response in patients with T2D, compared to exercise at high intensity? Hypothesis: Considering the pathological condition of T2D skeletal muscle (i.e. high chronic ROS level), it is hypothesized that a lower exercise intensity, leading to a lower exercise-stimulated ROS production is a more optimal stimulus (i.e. not to high) for mitochondrial biogenesis in patients with T2D.
Material and methodology:
20 patients with T2D (non-insulin dependent) and 20 healthy controls will be recruited to the study. The two groups will be matched on age, weight and maximal oxygen consumption (VO2 max).
Approach for the study: The study is a double blinded randomized placebo controlled trial.
At each attendance to the laboratory (except for the day of screening), the subjects are asked to:
- Report to the laboratory in an overnight fasted state
- Abstain from alcohol and physical activity 24 hours prior to each study day.
- Repeat the same diet as the enclosed 24-hour recall questionnaire prescribes (the subjects are also asked to complete a 24-hour dietary recall questionnaire on their first attendance to the laboratory)
Screening: Before the subjects are included in the study, a standard clinical examination will be conducted, including medical history, glycated hemoglobin (HbA1c) and ECG.
If included in the study, the subjects undergoes 3 experimental days before and after the intervention.
Test day 1:
- Dual Energy X-ray Absorptiometry-scan to measure body composition,
- Incremental exercise test to determine the exercise intensity that elicits maximal fat oxidation (Fatmax test)
- Incremental exercise test to exhaustion to determine VO2 max.
Test day 2:
- Muscle biopsies from vastus lateralis (basal, immediately after exercise cessation and after 90 min of recovery)
- Acute exercise tests on bicycle ergometers at 70% of VO2 max (moderate intensity) or at 50% of VO2 max (low intensity). The two exercise tests will be matched for total amount of work (kJ). 10 subjects with T2D and 10 control subjects are randomized to each exercise test.
Test day 3:
- Measurement of resting metabolic rate by canopy hood (basal and during the clamp)
- Intravenous glucose tolerance test
- Hyperinsulinaemic euglycaemic clamp
After the experimental days, the subjects are randomized into placebo or GSH supplementation and instructed to consume either 1000 mg GSH/day or placebo daily (2 tablets in the morning and 2 tablets in the evening) for 4 weeks.
Statistical considerations:
The comparison of the groups or the interventions will be performed using a one-way or a two-way ANOVA test with repeated measures, as appropriate. Based on the variation shown in previous studies an expected 80% power and a significance level of P<0.05, power calculations have shown that 12 subjects in each group is sufficient in regards to mitochondrial functionality measurements and insulin sensitivity. Data from a previous study investigating GSH in healthy subjects indicates that 15 subjects are needed in order to find a difference in this parameter (3).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Placebo4 placebo tablets/day (2 in the morning and 2 in the evening) |
| Glutathione | Active comparator | Dietary Supplement: Glutathione4 oral GSH tablets/day (2 in the morning and 2 in the evening) |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male
- 30-50 years
- BMI: 28-35
- ECG with no evidence of heart disease
- HbA1c > 6.5% (48mmol/mol)
Key exclusion criteria (7 listed)
- Insulin treatment
- Antioxidant supplementation or other dietary supplements
- Cholesterol lowering medicine
- Antioxidant supplementation or other dietary supplements
- Cholesterol lowering medicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlutathioneAlso: Setria Glutathion4 oral GSH tablets/day (1000mg/day) for 4 weeks | Dietary supplement | Glutathione |
| Placebo4 oral placebo tablets for 4 weeks | Other | Control |
Primary outcome
Insulin sensitivity
Time frame: 12 weeks
Difference in insulin sensitivity (measured as glucose infusion rate during a hyperinsulinaemic euglycaemic clamp) between patients with type 2 diabetes receiving glutathione supplementation and patients with type 2 diabetes receiving placebo.
1 secondary outcome
Mitochondrial reactive oxygen species production
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Background: PubMed 3289989DeFronzo RA. Lilly lecture 1987. The triumvirate: beta-cell, muscle, liver. A collusion responsible for NIDDM. Diabetes. 1988 Jun;37(6):667-87. doi: 10.2337/diab.37.6.667. No abstract available.
- Background: PubMed 16612386Houstis N, Rosen ED, Lander ES. Reactive oxygen species have a causal role in multiple forms of insulin resistance. Nature. 2006 Apr 13;440(7086):944-8. doi: 10.1038/nature04634.
- Background: PubMed 19188683Anderson EJ, Lustig ME, Boyle KE, Woodlief TL, Kane DA, Lin CT, Price JW 3rd, Kang L, Rabinovitch PS, Szeto HH, Houmard JA, Cortright RN, Wasserman DH, Neufer PD. Mitochondrial H2O2 emission and cellular redox state link excess fat intake to insulin resistance in both rodents and humans. J Clin Invest. 2009 Mar;119(3):573-81. doi: 10.1172/JCI37048. Epub 2009 Feb 2.
- Background: PubMed 19183935Abdul-Ghani MA, Jani R, Chavez A, Molina-Carrion M, Tripathy D, Defronzo RA. Mitochondrial reactive oxygen species generation in obese non-diabetic and type 2 diabetic participants. Diabetologia. 2009 Apr;52(4):574-82. doi: 10.1007/s00125-009-1264-4. Epub 2009 Jan 30.
- Background: PubMed 20526759Hey-Mogensen M, Hojlund K, Vind BF, Wang L, Dela F, Beck-Nielsen H, Fernstrom M, Sahlin K. Effect of physical training on mitochondrial respiration and reactive oxygen species release in skeletal muscle in patients with obesity and type 2 diabetes. Diabetologia. 2010 Sep;53(9):1976-85. doi: 10.1007/s00125-010-1813-x. Epub 2010 Jun 6.
- Background: PubMed 20382691Chanseaume E, Barquissau V, Salles J, Aucouturier J, Patrac V, Giraudet C, Gryson C, Duche P, Boirie Y, Chardigny JM, Morio B. Muscle mitochondrial oxidative phosphorylation activity, but not content, is altered with abdominal obesity in sedentary men: synergism with changes in insulin sensitivity. J Clin Endocrinol Metab. 2010 Jun;95(6):2948-56. doi: 10.1210/jc.2009-1938. Epub 2010 Apr 9.
- Background: PubMed 19061483Murphy MP. How mitochondria produce reactive oxygen species. Biochem J. 2009 Jan 1;417(1):1-13. doi: 10.1042/BJ20081386.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steen Larsen, Ass. prof. principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glutathione in people with Type 2 Diabetes and Oxidative Stress, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02948673, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.