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Normal Cellular MetabolismPhase 1NCT02748369

In Vivo Assessment of Cellular Metabolism in Humans

A Phase 1 study testing Somatostatin and Glucagon in people with Normal Cellular Metabolism, run by K. Sreekumaran Nair at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a pilot study to establish an arterial venous methodology to measure the activity of the TCA cycle or flux directly in tissues of human beings. It will also perform correlative studies to study the proteome, metabolome, oxygen consumption, carbon dioxide production and exosomes derived from the arterial venous… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Normal Cellular Metabolism
What is being tested?
Somatostatin and Glucagon
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
Jul 2016to 2 Mar 2017
Phase
Phase 1
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 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Ages 18-45
  • Able to provide written consent

Who cannot join

  • Diabetes mellitus or impaired fasting glucose levels (fasting blood glucose >110mg/dl).
  • Renal Failure
  • Pregnancy
  • Steroid use
  • Muscle Disease
  • Liver Disease
Show all 11Show fewer
  • Major Depression
  • Anemia
  • H/O alcohol use
  • Medications other than OCPs
  • BMI of 30 or greater

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: In Vivo Assessment of the Tricarboxylic Acid Cycle Flux in the Muscle and Splanchnic Bed of Humans: A Pilot Study

This is a pilot study to establish an arterial venous methodology to measure the activity of the TCA cycle or flux directly in tissues of human beings. It will also perform correlative studies to study the proteome, metabolome, oxygen consumption, carbon dioxide production and exosomes derived from the arterial venous supply of tissues with correlation to the TCA cycle activity.

Read the detailed description

The tricarboxylic (TCA) or Krebs cycle is the "central hub of cellular metabolism" that takes place within the mitochondria. It is a series of sequential chemical reactions that generate cellular energy in the form of ATP. In addition, the cycle provides intermediate metabolites that are utilized in the biosynthesis of amino acids and fatty acids as well as reducing agents such as nicotinamide adenine dinucleotide (NADH) and flavin adenine dinucleotide (FADH2) that are used in numerous biochemical reactions. The dysfunction of the TCA cycle is recognized for its association in neurodegenerative and cardiovascular diseases, metabolic syndromes, tumorigenesis and aging. Hence, being able to measure the activity or flux of the TCA cycle either in vitro or in vivo holds significant clinical significance. Almost all studies are based on in vitro approaches except NMRS based studies that involve multiple non-validated assumptions.

Various stable isotope labeling studies have been used to estimate the TCA cycle flux by measuring one or more labelled intermediate metabolites within the cycle. Unfortunately, these labelled intermediates are often present through only partial segments of the cycle due to exchange, anaplerosis (entrance into the cycle), cataplerosis (export out of the cycle) or incomplete cycling. Though these previous isotope labeling studies of the TCA cycle flux were qualitatively informative, many were quantitatively inaccurate due to unexpected dilutions of the TCA cycle intermediates arising from unlabeled precursors.

This is a pilot study to establish a novel methodology using mass-isotopomer flux analysis after infusions of 2-13C-Acetate, 2-15N-Glutamine and D5-phenylalanine to measure the in vivo TCA cycle flux in tissues of human beings. This study will simultaneously determine the validity of measuring the TCA cycle flux in tissue indirectly through dynamic differences in enrichment of labelled TCA cycle intermediates between arterial and venous blood supplies of that particular tissue bed (i.e. arteriovenous model or A-V balance technique). We propose to measure the rates of the different metabolic reactions within the TCA cycle by tracing the position-specific 13C and 15N transfer between the intermediate metabolites in order to characterize the oxidative, anaplerotic, cataplerotic and exchange rates across the TCA cycle. The use of 2-15N-Glutamine will specifically allow us to determine the rate of glutamine entry into the cycle via its conversion to glutamate, thus providing a more accurate quantification of the TCA flux.

This methodology will be validated in the setting of controlled physiologic perturbations in human study participants such as low endogenous insulin levels alone or in combination with high glucagon levels.

Finally, correlative studies evaluating the mitochondrial activity in the skeletal muscle tissue, the oxygen consumption in the skeletal and splanchnic tissue beds, the role of circulating exosomes derived from the arteriovenous circulation of the skeletal and splanchnic tissue beds and the changes in the whole body metabolome will also be performed:

  • First, mitochondrial respiration will be measured by high resolution respirometry (Oxygraph, Oroboros Instruments, Innsbruck, Austria) using a stepwise protocol to evaluate various components of the electron transport system. Protein content of the mitochondrial suspension will be measured using a colorimetric assay (Pierce 660-nm Protein Assay). Oxygen flux rates will be expressed per tissue-wet weight and per milligram of mitochondrial protein.
  • Secondly, reactive oxygen species (ROS) emissions will also be evaluated on all skeletal muscle tissue samples. Briefly, a Fluorolog 3 (Horiba Jobin Yvon) spectrofluorometer with temperature control and continuous stirring will be used to monitor Amplex Red (Invitrogen) oxidation in freshly isolated mitochondrial suspensions obtained from the skeletal muscle biopsies. Amplex Red oxidation will be measured in the presence of glutamate (10 mmol/L), malate (2 mmol/L), and succinate (10 mmol/L). The fluorescent signal will be corrected for background auto-oxidation and calibrated to a standard curve. The H2O2 production rates will be expressed relative to mitochondrial protein.
  • Third, simultaneous assessments of the oxygen consumption and carbon dioxide production will be determined through blood gas measurements from the arteriovenous samples obtained from the splanchnic and skeletal muscle tissue beds. These assessments will be performed at all three time points of blood sample assessments and correlated with the measured TCA cycle flux in their respective tissue beds.
  • Circulating exosomes will also be derived from the arteriovenous samples of the splanchnic and skeletal muscle tissue beds to determine its intra-exosome proteome and metabolome and its relationship with the TCA cycle flux in their respective tissue beds. Incorporation of D5-phenylalanine will help trace the protein formation in the exosomes.
  • Finally, changes in the whole body metabolome and proteome determined via the arteriovenous samples obtained from the splanchnic and skeletal muscle tissue beds will also be performed and correlated with the TCA cycle flux in their respective tissue beds.
Being tested
Somatostatin, Glucagon
Keywords
TCA cycle flux, in vivo measurements, Stable isotopes, Arteriovenous balance, Metabolome, Proteome, Exosomes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SomatostatinDrug

    Also called growth hormone-inhibiting hormone

    Somatostatin infusion to create a low insulin state.

  • GlucagonDrug

    Also called Glucagen

    Glucagon infusion in the setting of ongoing somatostatin.

Study groups in NCT02748369
Study groupRoleWhat they receive
Control GroupNo interventionNo somatostatin and glucagon infusions
Intervention GroupActive comparatorSomatostatin and glucagon infusions
Receives: Drug: Somatostatin; Drug: Glucagon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In Vivo TCA cycle flux in skeletal muscle and splanchnic tissue

    Normal healthy study participants will receive an initial priming dose followed by a continuous infusion of 2-13C-Acetate, 2-15N-Glutamine and D5-Phenylalanine in order to achieve steady state enrichment of 13C and 15N in their system. Serial arteriovenous blood samples will be obtained from the femoral artery, femoral vein and hepatic vein and serial skeletal muscle tissue biopsies will be obtained from the vastus lateralis. These samples will be analyzed by GC-MS and NMR spectroscopy to quantify the isotopomer intermediates of the TCA cycle and measure the corresponding TCA cycle flux. The flux estimations from the arteriovenous blood samples will be compared to that obtained directly from the skeletal muscle tissue. This methodology will be validated in the setting of low insulin levels alone or in combination with high glucagon concentrations.

    Measured: 12 hours

Secondary outcomes (6)
  1. Changes in the protein and metabolite contents within circulating exosomes derived from the arterial-venous blood supply of the skeletal muscle and splanchnic tissue

    Measured: 12 hours

  2. Changes in the metabolome derived from the arterial-venous blood supply of the skeletal muscle and splanchnic tissue

    Measured: 12 hours

  3. Changes in the proteome derived from the arterial-venous blood supply of the skeletal muscle and splanchnic tissue in response to hormonal manipulation.

    Measured: 12 hours

  4. Oxygen consumption in skeletal muscle and splanchnic tissue in response to hormonal manipulation

    Measured: 12 hours

  5. Mitochondrial respiration in skeletal muscle tissue

    Measured: 12 hours

  6. Reactive oxygen species emissions in skeletal muscle tissue

    Measured: 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2016 (estimated)
  2. Study startJul 2016
  3. Primary completion2 Mar 2017
  4. Study completion2 Mar 2017

Resources

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 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02748369
Sponsor's protocol ID
16-000085
Other IDs
U24DK100469
Status last verified
Aug 2022
First submitted
12 Apr 2016
Last updated
3 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Akram M. Citric acid cycle and role of its intermediates in metabolism. Cell Biochem Biophys. 2014 Apr;68(3):475-8. doi: 10.1007/s12013-013-9750-1.

    PubMed 24068518
  • Befroy DE, Perry RJ, Jain N, Dufour S, Cline GW, Trimmer JK, Brosnan J, Rothman DL, Petersen KF, Shulman GI. Direct assessment of hepatic mitochondrial oxidative and anaplerotic fluxes in humans using dynamic 13C magnetic resonance spectroscopy. Nat Med. 2014 Jan;20(1):98-102. doi: 10.1038/nm.3415. Epub 2013 Dec 8.

    PubMed 24317120
  • Sunny NE, Parks EJ, Browning JD, Burgess SC. Excessive hepatic mitochondrial TCA cycle and gluconeogenesis in humans with nonalcoholic fatty liver disease. Cell Metab. 2011 Dec 7;14(6):804-10. doi: 10.1016/j.cmet.2011.11.004.

    PubMed 22152305
  • Schumann WC, Magnusson I, Chandramouli V, Kumaran K, Wahren J, Landau BR. Metabolism of [2-14C]acetate and its use in assessing hepatic Krebs cycle activity and gluconeogenesis. J Biol Chem. 1991 Apr 15;266(11):6985-90.

    PubMed 2016310
  • Alves TC, Pongratz RL, Zhao X, Yarborough O, Sereda S, Shirihai O, Cline GW, Mason G, Kibbey RG. Integrated, Step-Wise, Mass-Isotopomeric Flux Analysis of the TCA Cycle. Cell Metab. 2015 Nov 3;22(5):936-47. doi: 10.1016/j.cmet.2015.08.021. Epub 2015 Sep 24.

    PubMed 26411341
  • Jones JG, Solomon MA, Cole SM, Sherry AD, Malloy CR. An integrated (2)H and (13)C NMR study of gluconeogenesis and TCA cycle flux in humans. Am J Physiol Endocrinol Metab. 2001 Oct;281(4):E848-56. doi: 10.1152/ajpendo.2001.281.4.E848.

    PubMed 11551863

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Somatostatin and Glucagon in people with Normal Cellular Metabolism, run by K. Sreekumaran Nair at 1 site in United States.

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 2 inclusion and 11 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 3 Aug 2022. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

In Vivo TCA cycle flux in skeletal muscle and splanchnic tissue (time frame: 12 hours). 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 NCT02748369, which also lists 6 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 3 Aug 2022.

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