SarcopeniaIncretinNCT02370745
Characterizing the Incretin Effect of Amino Acids and Defining GLP-1 Role on Skeletal Muscle
A study testing GLP-1, Insulin Actrapid and Oral amino acids in people with Sarcopenia, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
This study has two protocols the aims of which are: 1. To identify age-related effects of AA on incretin secretion and whether and to what extent AA exhibit a true incretin effect (gut- mediated increases in plasma insulin) in younger individuals. (Protocol 1) 2. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- GLP-1, Insulin Actrapid and Oral amino acids
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to Mar 2018
- 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 18 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For protocol 1: i. Aged between 18-40 or 65-75 years ii. A body mass index (BMI) >18 and <28 kg/m2
- For Protocol 2: i. Age 65-75 years ii. A body mass index (BMI) >18 and <28 kg/m2
Who cannot join
- For protocol 1:
- A BMI < 18 or > 28 kg·m2 ii. Active cardiovascular disease: uncontrolled hypertension (BP > 160/100), angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt or recent cardiac event iii. Cerebrovascular disease: previous stroke, aneurysm (large vessel or intracranial) iv. Respiratory disease including pulmonary hypertension, chronic obstructive pulmonary disease (COPD), asthma or an forced expiratory volume in 1 minute (FEV1) less than 1.5 litre.
- Metabolic disease: hyper and hypo-parathyroidism, untreated hyper and hypothyroidism, Cushing's disease, types 1 or 2 diabetes vi. Active inflammatory bowel or renal disease vii. Malignancy viii. Recent steroid treatment (within 6 month), or hormone replacement therapy ix. Clotting dysfunction x. Musculoskeletal or neurological disorders xi. Family history of early (<55y) death from cardiovascular disease
- For protocol 2:
- Same as protocol 1 in addition to:
- Overt muscle wasting i.e. muscle mass is more than 1 standard deviation below normal muscle or fat-free mass for age.
- Taking beta-adrenergic blocking agents or non-steroidal anti-inflammatory drugs iii. Known sensitivity to SONOVUE or any other drug used in the study. iv. Subject deemed unsuitable for femoral cannulation at screening visit.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Division of Medical Sciences and Graduate Entry Medicine - School of Medicine - University of Nottingham
Derby, DE22 3DT
About this study
Official title: Characterizing the Incretin Effect of Amino Acids (AA) and Defining the Effect of GLP-1 on Muscle Microvascular Blood Flow and Muscle Protein and Glucose Metabolism in Older Age.
This study has two protocols the aims of which are:
- To identify age-related effects of AA on incretin secretion and whether and to what extent AA exhibit a true incretin effect (gut- mediated increases in plasma insulin) in younger individuals. (Protocol 1)
- To define the extra-pancreatic ''novel'', insulin independent effects of glucagon like peptide-1 (GLP-1) on postprandial muscle protein and glucose metabolism and microvascular blood flow. (Protocol 2)
Read the detailed description
Protocol 1:
This will explore the first aim. 8 Healthy younger volunteers will be recruited to under go 3 arms cross over studies. Interventions will include oral and intravenous amino acids, in addition to intravenous GLP-1 and glucose dependent insulinotropic polypeptide (GIP).
8 older subjects also will be recruited for comparison of the response of GI hormones to amino acids oral feed between young and older men.
Therefore the total number will be recruited to perform this protocol is 16.
Post intervention in all visits, measurements will be taken for:
Insulin, Amino acids, GLP-1, GIP, Ghrelin and peptide YY (PYY).
The measurable end points for this protocol are:
- Gut hormones levels in response to the 2 methods of AA delivery (I.V and oral)
- Differences in gut hormones levels between young and older subjects when AA's are delivered orally
Protocol 2:
This will explore the second aim. 16 healthy older subjects will be recruited and subdivided randomly into two groups to receive either post absorptive or postprandial insulin concentrations with or without GLP-1 at physiological ranges in a cross over fashion . During acute study parameters of muscle glucose and amino acids metabolism will be tested together with muscle microvascular recruitment and macro vascular flow in the tested leg.
The measurable end points for this protocol are:
- Muscle Glucose uptake, assessed by measuring 2-deoxyglucose (2-DOG) phosphate in muscle biopsies
- Myofibrillar protein synthesis, assessed via muscle biopsy fractional synthesis rate (FSR)
- Whole Leg Muscle Protein Synthesis, assessed via Arterial-Venous difference (AV method)
- Whole Leg Muscle Protein Breakdown, assessed via AV method
- Whole Leg Net Protein Balance, assessed via AV method
- Muscle microvascular recruitment, assessed via microvascular contrast bubbles filling and refilling post destruction by ultrasound waves.
- Conditions
- Sarcopenia
- Being tested
- GLP-1, Insulin Actrapid, Oral amino acids, GIP, Intravenous amino acids
- Keywords
- Incretin, GLP-1, Skeletal muscle metabolism, Microvascular recruitment, Amino Acids, Microvascular blood flow
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1Drug
Also called Incretin
GLP-1 effects on skeletal muscle glucose and amino acid metabolism and microvascular blood flow will be scrutinised under the specified insulin concentrations. It will also be used to test the effect of intravenous feed on insulin secretion.
Insulin ActrapidDrug
Also called Actrapid
Skeletal muscle metabolic and microvascular parameters will be tested under specified insulin concentrations with or without GLP-1
Oral amino acidsDietary supplement
Also called mixed EAA
Oral amino acids containing 15 g of amino acids
GIPDrug
Also called Incretin
This will be co infused with GLP-1 and intravenous amino acids
Intravenous amino acidsDrug
Also called IV AA
This will aim to deliver iso equivalent amount to the amino acids administered orally
| Study group | Role | What they receive |
|---|---|---|
| Post absorptive insulin without GLP-1 | Experimental | Subjects with receive post absorptive insulin concentrations while measures of muscle metabolism and microvascular blood flow are taken through the acute study hours.
The intervention in this group is Insulin Actrapid to achieve post absorptive insulin levels and glucose infusion to achieve postprandial glucose levels of 7.0-7.5 mmol/L . This will form base line measurement for the next arm which will receive GLP-1 in addition. Receives: Drug: Insulin Actrapid |
| Postabsorptive insulin with GLP-1 | Experimental | Subjects will receive post absorptive insulin concentrations with GLP-1 while measures of muscle metabolism and microvascular blood flow are taken through the acute study hours. This arm will cross over with the previous arm.
The intervention in this group is in the form of GLP-1, Insulin Actrapid to achieve post absorptive insulin levels and glucose infusion to achieve postprandial glucose levels of 7.0-7.5 mmol/L . Receives: Drug: GLP-1; Drug: Insulin Actrapid |
| Postprandial insulin without GLP-1 | Experimental | Subjects will receive postprandial insulin concentrations without GLP-1 while measures of muscle metabolism and microvascular blood flow are taken through the acute study hours.
The intervention in this group is Insulin Actrapid to achieve postprandial insulin levels and glucose infusion to achieve postprandial glucose levels of 7.0-7.5 mmol/L . This will form base line measurement for the next arm which will receive GLP-1 in addition Receives: Drug: Insulin Actrapid |
| Postprandial insulin with GLP-1 | Experimental | Subjects with receive postprandial insulin concentrations with GLP-1 while measures of muscle metabolism and microvascular blood flow are taken through the acute study hours. This arm will cross over with the previous arm.
The intervention in this group is in the form of GLP-1, Insulin Actrapid to achieve postprandial insulin levels and glucose infusion to achieve postprandial glucose levels of 7.0-7.5 mmol/L . Receives: Drug: GLP-1; Drug: Insulin Actrapid |
| Oral amino acids-Young | Experimental | Gut hormones will be measured post oral drink containing 15 g of amino acids in young persons. This will cross over with the following 2 arms.
The intervention here is: 15g of mixed essential amino acid drink. Receives: Dietary Supplement: Oral amino acids |
| Intravenous (IV) amino acids- Young | Experimental | Gut hormones will be measured after intravenous amino acid infusion delivering iso equivalent amount of amino acids in young persons.
The intervention in this group: Intravenous amino acids delivering iso-equivalent amount of 15g mixed essential amino acids Receives: Drug: Intravenous amino acids |
| IV amino acids, GLP-1, GIP -Young | Experimental | Gut hormones will be measured after intravenous amino acid infusion delivering iso equivalent amount of amino acids, GLP-1, GIP in young persons.
The intervention in this group: Intravenous amino acids iso-equivalent to oral 15 g mixed essential amino acids, GLP-1 infusion and GIP infusion Receives: Drug: GLP-1; Drug: GIP; Drug: Intravenous amino acids |
| Oral amino acids- Older | Experimental | Gut hormones will be measured post oral drink containing 15 g of mixed essential amino acids in older persons.
The intervention in this arm: 15 gram of oral mixed essential amino acid drink Receives: Dietary Supplement: Oral amino acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein and glucose metabolism
Assessed from muscle biopsies taken for measurement of protein synthesis and breakdown and glucose uptake.
Measured: 12 months
Secondary outcomes (4)
Leg Microvascular blood flow
Assessed via contrast enhanced ultrasound.
Measured: 12 months
Leg Macrovascular blood flow
Assessed via ultrasound doppler scans
Measured: 12 months
Insulin secretion in response to oral and intravenous amino acids to assess their ability to exert incretin effect.
Assessed via serial blood draws measuring insulin level at baseline and and post intervention.
Measured: 12 months
Gut hormones secretion in response to amino acids in young and older people
Assessed via serial blood draws measuring gut hormones at baseline and post intervention.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip Atherton, PhD, Principal investigator, University of NottinghamIskandar Idris, DM, FRCP, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370745
- Sponsor's protocol ID
- G12122013 MSGEM
- Acronym
- Incretin
- Status last verified
- Mar 2018
- First submitted
- 10 Nov 2014
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Nilsson M, Holst JJ, Bjorck IM. Metabolic effects of amino acid mixtures and whey protein in healthy subjects: studies using glucose-equivalent drinks. Am J Clin Nutr. 2007 Apr;85(4):996-1004. doi: 10.1093/ajcn/85.4.996.
PubMed 17413098Hall WL, Millward DJ, Long SJ, Morgan LM. Casein and whey exert different effects on plasma amino acid profiles, gastrointestinal hormone secretion and appetite. Br J Nutr. 2003 Feb;89(2):239-48. doi: 10.1079/BJN2002760.
PubMed 12575908Wilkes EA, Selby AL, Atherton PJ, Patel R, Rankin D, Smith K, Rennie MJ. Blunting of insulin inhibition of proteolysis in legs of older subjects may contribute to age-related sarcopenia. Am J Clin Nutr. 2009 Nov;90(5):1343-50. doi: 10.3945/ajcn.2009.27543. Epub 2009 Sep 9.
PubMed 19740975Sjoberg KA, Holst JJ, Rattigan S, Richter EA, Kiens B. GLP-1 increases microvascular recruitment but not glucose uptake in human and rat skeletal muscle. Am J Physiol Endocrinol Metab. 2014 Feb 15;306(4):E355-62. doi: 10.1152/ajpendo.00283.2013. Epub 2013 Dec 3.
PubMed 24302010Chai W, Dong Z, Wang N, Wang W, Tao L, Cao W, Liu Z. Glucagon-like peptide 1 recruits microvasculature and increases glucose use in muscle via a nitric oxide-dependent mechanism. Diabetes. 2012 Apr;61(4):888-96. doi: 10.2337/db11-1073. Epub 2012 Feb 22.
PubMed 22357961Abdulla H, Phillips B, Wilkinson D, Gates A, Limb M, Jandova T, Bass J, Lewis J, Williams J, Smith K, Idris I, Atherton P. Effects of GLP-1 Infusion Upon Whole-body Glucose Uptake and Skeletal Muscle Perfusion During Fed-state in Older Men. J Clin Endocrinol Metab. 2023 Mar 10;108(4):971-978. doi: 10.1210/clinem/dgac613.
PubMed 36260533
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
- Characterizing the Incretin Effect of Amino Acids (AA) and Defining the Effect of GLP-1 on Muscle Microvascular Blood Flow and Muscle Protein and Glucose Metabolism in Older Age.
- ClinicalTrials.gov ID
- NCT02370745
- Acronym / sponsor ID
- Incretin / G12122013 MSGEM
- Conditions
- Sarcopenia
- Keywords
- Incretin, GLP-1, Skeletal muscle metabolism, Microvascular recruitment, Amino Acids, Microvascular blood flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 25 Feb 2015 (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.
This study has two protocols the aims of which are:
- To identify age-related effects of AA on incretin secretion and whether and to what extent AA exhibit a true incretin effect (gut- mediated increases in plasma insulin) in younger individuals. (Protocol 1)
- To define the extra-pancreatic ''novel'', insulin independent effects of glucagon like peptide-1 (GLP-1) on postprandial muscle protein and glucose metabolism and microvascular blood flow. (Protocol 2)
Detailed description
Protocol 1:
This will explore the first aim. 8 Healthy younger volunteers will be recruited to under go 3 arms cross over studies. Interventions will include oral and intravenous amino acids, in addition to intravenous GLP-1 and glucose dependent insulinotropic polypeptide (GIP).
8 older subjects also will be recruited for comparison of the response of GI hormones to amino acids oral feed between young and older men.
Therefore the total number will be recruited to perform this protocol is 16.
Post intervention in all visits, measurements will be taken for:
Insulin, Amino acids, GLP-1, GIP, Ghrelin and peptide YY (PYY).
The measurable end points for this protocol are:
- Gut hormones levels in response to the 2 methods of AA delivery (I.V and oral)
- Differences in gut hormones levels between young and older subjects when AA's are delivered orally
Protocol 2:
This will explore the second aim. 16 healthy older subjects will be recruited and subdivided randomly into two groups to receive either post absorptive or postprandial insulin concentrations with or without GLP-1 at physiological ranges in a cross over fashion . During acute study parameters of muscle glucose and amino acids metabolism will be tested together with muscle microvascular recruitment and macro vascular flow in the tested leg.
The measurable end points for this protocol are:
- Muscle Glucose uptake, assessed by measuring 2-deoxyglucose (2-DOG) phosphate in muscle biopsies
- Myofibrillar protein synthesis, assessed via muscle biopsy fractional synthesis rate (FSR)
- Whole Leg Muscle Protein Synthesis, assessed via Arterial-Venous difference (AV method)
- Whole Leg Muscle Protein Breakdown, assessed via AV method
- Whole Leg Net Protein Balance, assessed via AV method
- Muscle microvascular recruitment, assessed via microvascular contrast bubbles filling and refilling post destruction by ultrasound waves.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Post absorptive insulin without GLP-1 | Experimental | Drug: Insulin ActrapidSubjects with receive post absorptive insulin concentrations while measures of muscle metabolism and microvascular blood flow are taken through the acute study hours. The intervention in this group is Insulin Actrapid to achieve post absorptive insulin levels and glucose infusion to achieve postprandial glucose levels of 7.0-7.5 mmol/L . This will form base line measurement for the next arm which will receive GLP-1 in addition. |
| Postabsorptive insulin with GLP-1 | Experimental | Drug: GLP-1, Drug: Insulin ActrapidSubjects will receive post absorptive insulin concentrations with GLP-1 while measures of muscle metabolism and microvascular blood flow are taken through the acute study hours. This arm will cross over with the previous arm. The intervention in this group is in the form of GLP-1, Insulin Actrapid to achieve post absorptive insulin levels and glucose infusion to achieve postprandial glucose levels of 7.0-7.5 mmol/L . |
| Postprandial insulin without GLP-1 | Experimental | Drug: Insulin ActrapidSubjects will receive postprandial insulin concentrations without GLP-1 while measures of muscle metabolism and microvascular blood flow are taken through the acute study hours. The intervention in this group is Insulin Actrapid to achieve postprandial insulin levels and glucose infusion to achieve postprandial glucose levels of 7.0-7.5 mmol/L . This will form base line measurement for the next arm which will receive GLP-1 in addition |
| Postprandial insulin with GLP-1 | Experimental | Drug: GLP-1, Drug: Insulin ActrapidSubjects with receive postprandial insulin concentrations with GLP-1 while measures of muscle metabolism and microvascular blood flow are taken through the acute study hours. This arm will cross over with the previous arm. The intervention in this group is in the form of GLP-1, Insulin Actrapid to achieve postprandial insulin levels and glucose infusion to achieve postprandial glucose levels of 7.0-7.5 mmol/L . |
| Oral amino acids-Young | Experimental | Dietary Supplement: Oral amino acidsGut hormones will be measured post oral drink containing 15 g of amino acids in young persons. This will cross over with the following 2 arms. The intervention here is: 15g of mixed essential amino acid drink. |
| Intravenous (IV) amino acids- Young | Experimental | Drug: Intravenous amino acidsGut hormones will be measured after intravenous amino acid infusion delivering iso equivalent amount of amino acids in young persons. The intervention in this group: Intravenous amino acids delivering iso-equivalent amount of 15g mixed essential amino acids |
| IV amino acids, GLP-1, GIP -Young | Experimental | Drug: GLP-1, Drug: GIP, Drug: Intravenous amino acidsGut hormones will be measured after intravenous amino acid infusion delivering iso equivalent amount of amino acids, GLP-1, GIP in young persons. The intervention in this group: Intravenous amino acids iso-equivalent to oral 15 g mixed essential amino acids, GLP-1 infusion and GIP infusion |
| Oral amino acids- Older | Experimental | Dietary Supplement: Oral amino acidsGut hormones will be measured post oral drink containing 15 g of mixed essential amino acids in older persons. The intervention in this arm: 15 gram of oral mixed essential amino acid drink |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- For protocol 1: i. Aged between 18-40 or 65-75 years ii. A body mass index (BMI) >18 and <28 kg/m2
- For Protocol 2: i. Age 65-75 years ii. A body mass index (BMI) >18 and <28 kg/m2
Key exclusion criteria (7 listed)
- For protocol 1:
- For protocol 2:
- Overt muscle wasting i.e. muscle mass is more than 1 standard deviation below normal muscle or fat-free mass for age.
- Taking beta-adrenergic blocking agents or non-steroidal anti-inflammatory drugs iii. Known sensitivity to SONOVUE or any other drug used in the study. iv. Subject deemed unsuitable for femoral cannulation at screening visit.
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 |
|---|---|---|
| GLP-1Also: IncretinGLP-1 effects on skeletal muscle glucose and amino acid metabolism and microvascular blood flow will be scrutinised under the specified insulin concentrations. It will also be used to test the effect of intravenous feed on insulin secretion. | Drug | IV amino acids, GLP-1, GIP -Young, Postabsorptive insulin with GLP-1, Postprandial insulin with GLP-1 |
| Insulin ActrapidAlso: ActrapidSkeletal muscle metabolic and microvascular parameters will be tested under specified insulin concentrations with or without GLP-1 | Drug | Post absorptive insulin without GLP-1, Postabsorptive insulin with GLP-1, Postprandial insulin with GLP-1, Postprandial insulin without GLP-1 |
| Oral amino acidsAlso: mixed EAAOral amino acids containing 15 g of amino acids | Dietary supplement | Oral amino acids- Older, Oral amino acids-Young |
| GIPAlso: IncretinThis will be co infused with GLP-1 and intravenous amino acids | Drug | IV amino acids, GLP-1, GIP -Young |
| Intravenous amino acidsAlso: IV AAThis will aim to deliver iso equivalent amount to the amino acids administered orally | Drug | IV amino acids, GLP-1, GIP -Young, Intravenous (IV) amino acids- Young |
Primary outcome
Muscle protein and glucose metabolism
Time frame: 12 months
Assessed from muscle biopsies taken for measurement of protein synthesis and breakdown and glucose uptake.
4 secondary outcomes
Leg Microvascular blood flow
Time frame: 12 months
Leg Macrovascular blood flow
Time frame: 12 months
Insulin secretion in response to oral and intravenous amino acids to assess their ability to exert incretin effect.
Time frame: 12 months
Gut hormones secretion in response to amino acids in young and older people
Time frame: 12 months
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 17413098Nilsson M, Holst JJ, Bjorck IM. Metabolic effects of amino acid mixtures and whey protein in healthy subjects: studies using glucose-equivalent drinks. Am J Clin Nutr. 2007 Apr;85(4):996-1004. doi: 10.1093/ajcn/85.4.996.
- Background: PubMed 12575908Hall WL, Millward DJ, Long SJ, Morgan LM. Casein and whey exert different effects on plasma amino acid profiles, gastrointestinal hormone secretion and appetite. Br J Nutr. 2003 Feb;89(2):239-48. doi: 10.1079/BJN2002760.
- Background: PubMed 19740975Wilkes EA, Selby AL, Atherton PJ, Patel R, Rankin D, Smith K, Rennie MJ. Blunting of insulin inhibition of proteolysis in legs of older subjects may contribute to age-related sarcopenia. Am J Clin Nutr. 2009 Nov;90(5):1343-50. doi: 10.3945/ajcn.2009.27543. Epub 2009 Sep 9.
- Background: PubMed 24302010Sjoberg KA, Holst JJ, Rattigan S, Richter EA, Kiens B. GLP-1 increases microvascular recruitment but not glucose uptake in human and rat skeletal muscle. Am J Physiol Endocrinol Metab. 2014 Feb 15;306(4):E355-62. doi: 10.1152/ajpendo.00283.2013. Epub 2013 Dec 3.
- Background: PubMed 22357961Chai W, Dong Z, Wang N, Wang W, Tao L, Cao W, Liu Z. Glucagon-like peptide 1 recruits microvasculature and increases glucose use in muscle via a nitric oxide-dependent mechanism. Diabetes. 2012 Apr;61(4):888-96. doi: 10.2337/db11-1073. Epub 2012 Feb 22.
- Derived from this study: PubMed 36260533Abdulla H, Phillips B, Wilkinson D, Gates A, Limb M, Jandova T, Bass J, Lewis J, Williams J, Smith K, Idris I, Atherton P. Effects of GLP-1 Infusion Upon Whole-body Glucose Uptake and Skeletal Muscle Perfusion During Fed-state in Older Men. J Clin Endocrinol Metab. 2023 Mar 10;108(4):971-978. doi: 10.1210/clinem/dgac613.
- Individual participant dataSharing planned: Undecided
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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.
Philip Atherton, PhD principal investigator
University of Nottingham
Iskandar Idris, DM, FRCP principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLP-1, Insulin Actrapid and Oral amino acids in people with Sarcopenia, run by University of Nottingham at 1 site in United Kingdom.
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 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 United Kingdom. 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.
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?
Muscle protein and glucose metabolism (time frame: 12 months). 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 NCT02370745, 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 2 May 2018; AzTrials last refreshed its copy on 8 Nov 2026.