Type 2 Diabetes MellitusPhase 1NCT02440061
Ghrelin and Beta Cell Function in Diabetes
A Phase 1 study testing Synthetic human AG, Arginine and 0.9% saline solution in people with Type 2 Diabetes Mellitus, run by Jenny Tong, MD, MPH at 1 site in United States.
Trial summary
Ghrelin is a hormone naturally produced in the stomach and the gut. The purpose of this research study is to determine the role of this gut hormone in the regulation of insulin secretion from the pancreas and glucose disposal after we eat. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Synthetic human AG, Arginine and 0.9% saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2018to Jun 2019
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- T2DM study subjects to be considered for the study must meet the following inclusion criteria:
- Established T2DM with good to moderate glycemic control
- HbA1c < 8.5%
- Diabetes treatment with metformin, sulfonylurea, thiazolidinediones or combination of these medications; with no use of insulin during the study period
- BMI ≤ 45.0 kg/m2
- Control study subjects will be matched for age- (± 2 years), BMI (± 1.5 kg/m2) and gender and must meet the following inclusion criteria:
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- HbA1c ≤ 5.7%
- Fasting plasma glucose ≤ 95 mg/dL
- BMI ≤ 45.0 kg/m2
Who cannot join
- All subjects will be excluded for the following reasons:
- History of myocardial infarction or arrhythmia within the past year, abnormal electrocardiogram (ECG) with evidence of ischemia or arrhythmia, history or symptoms of congestive heart failure
- Uncontrolled hypertension
- History or active liver or renal disease (AST or ALT >2x upper limits of normal, calculated glomerular filtration rate [eGFR] <60 at screening)
- History of pituitary or adrenal disorders or neuroendocrine tumor
- Anemia defined as hematocrit <33% at screening
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- Active cancer diagnosis or currently undergoing cancer treatment
- History of anorexia nervosa or previous gastrointestinal tract surgery
- Pregnancy or lactation
- Control subjects will be excluded for the following reasons:
- History or clinical evidence of impaired fasting glucose or impaired glucose tolerance on a 75 g OGTT, established diabetes mellitus, or taking medications prescribed for diabetes
- Use of medications that alter insulin sensitivity (i.e. niacin, glucocorticoids, metformin)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Center For Living
Durham, North Carolina, 27705
About this study
Official title: Ghrelin Effect on Beta Cell Function in Health and Disease #2
Ghrelin is a hormone naturally produced in the stomach and the gut. The purpose of this research study is to determine the role of this gut hormone in the regulation of insulin secretion from the pancreas and glucose disposal after we eat. The investigators hypothesize that ghrelin has an effect on the pancreas and on how our body handles glucose after we eat. The investigators will compare insulin secretion and glucose changes during meal ingestion while either acyl ghrelin (AG) or saline (salt solution) is being infused through your vein on separate study days. AG is a form of the ghrelin hormone that has a small modification to it that allows it to bind to a specific receptor. The investigators hypothesize that AG has an effect on how the body handles glucose after a meal. AG has been approved by the U.S. Food and Drug Administration (FDA) for human research only. This study will also involve the use of a medicine called arginine, which is a naturally occurring product and found in many nutritional supplements. Its use in this study is investigational. The use of arginine helps maximize insulin release from the pancreas so the investigators can better examine whether AG affects insulin secretion.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Synthetic human AG, Arginine, 0.9% saline solution
- Keywords
- Ghrelin, age, BMI, and gender matched controls
- 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.
Synthetic human AGDrug
Synthetic human AG (0.28 μg/kg) bolus over 1 minute followed by 2 μg/kg/hr continuous infusion for 4.5 hours.
ArginineDrug
Arginine hydrochloride (5 g) intravenously over 45 seconds.
0.9% saline solutionDrug
A continuous infusion of 0.9% saline solution (control) for 4.5 hours.
| Study group | Role | What they receive |
|---|---|---|
| Study Group: Type 2 Diabetes Mellitus (T2DM) | Active comparator | Subjects with Type 2 Diabetes Mellitus (T2DM). Subjects will receive AG and saline infusions, but the order of which they receive will be random and they will not be told which one they are receiving on each given visit. Arginine will be used at both study visits. Receives: Drug: Synthetic human AG; Drug: Arginine; Drug: 0.9% saline solution |
| Control Group | Active comparator | Control group of healthy subjects. Subjects will receive AG and saline, but the order of which they receive will be random and they will not be told which one they are receiving on each given visit. Arginine will be used at both study visits. Receives: Drug: Synthetic human AG; Drug: Arginine; Drug: 0.9% saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial insulin secretion (ISR-meal)
Postprandial insulin secretion (ISR-meal) will be derived from plasma C-peptide concentrations during MTT (0-240 min) using deconvolution with population estimates of C-peptide clearance.
Measured: approximately 8 weeks
Index of β-cell sensitivity to glucose
Index of β-cell sensitivity to glucose will be calculated as incremental insulin/glucose (I/G) AUC (ΔAUCI/G).
Measured: approximately 8 weeks
Whole body insulin sensitivity using the Matsuda Index
The Matsuda Index is a well-known index of insulin sensitivity derived from several glucose and insulin values obtained during a mixed meal
Measured: approximately 8 weeks
β-cell function (DI-meal)
β-cell function (DI-meal) will be calculated as ΔAUCI/G x Matsuda Index
Measured: approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMay 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Why it stopped: This protocol was replaced with a different one and therefore discontinued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jenny Tong, MD, MPH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jenny Tong, MD, MPH, Duke University
- Investigators
- Jenny Tong, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440061
- Sponsor's protocol ID
- Pro00060865
- Other IDs
- R01DK097550
- Status last verified
- Mar 2018
- First submitted
- 7 May 2015
- Last updated
- 2 Apr 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ghrelin Effect on Beta Cell Function in Health and Disease #2
- ClinicalTrials.gov ID
- NCT02440061
- Acronym / sponsor ID
- Pro00060865
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Ghrelin, age, BMI, and gender matched controls
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This protocol was replaced with a different one and therefore discontinued.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jenny Tong, MD, MPHUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 12 May 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.
Ghrelin is a hormone naturally produced in the stomach and the gut. The purpose of this research study is to determine the role of this gut hormone in the regulation of insulin secretion from the pancreas and glucose disposal after we eat. The investigators hypothesize that ghrelin has an effect on the pancreas and on how our body handles glucose after we eat. The investigators will compare insulin secretion and glucose changes during meal ingestion while either acyl ghrelin (AG) or saline (salt solution) is being infused through your vein on separate study days. AG is a form of the ghrelin hormone that has a small modification to it that allows it to bind to a specific receptor. The investigators hypothesize that AG has an effect on how the body handles glucose after a meal. AG has been approved by the U.S. Food and Drug Administration (FDA) for human research only. This study will also involve the use of a medicine called arginine, which is a naturally occurring product and found in many nutritional supplements. Its use in this study is investigational. The use of arginine helps maximize insulin release from the pancreas so the investigators can better examine whether AG affects insulin secretion.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group: Type 2 Diabetes Mellitus (T2DM) | Active comparator | Drug: Synthetic human AG, Drug: Arginine, Drug: 0.9% saline solutionSubjects with Type 2 Diabetes Mellitus (T2DM). Subjects will receive AG and saline infusions, but the order of which they receive will be random and they will not be told which one they are receiving on each given visit. Arginine will be used at both study visits. |
| Control Group | Active comparator | Drug: Synthetic human AG, Drug: Arginine, Drug: 0.9% saline solutionControl group of healthy subjects. Subjects will receive AG and saline, but the order of which they receive will be random and they will not be told which one they are receiving on each given visit. Arginine will be used at both study visits. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- T2DM study subjects to be considered for the study must meet the following inclusion criteria:
- Established T2DM with good to moderate glycemic control
- HbA1c < 8.5%
- Diabetes treatment with metformin, sulfonylurea, thiazolidinediones or combination of these medications; with no use of insulin during the study period
- BMI ≤ 45.0 kg/m2
Key exclusion criteria (12 listed)
- History of myocardial infarction or arrhythmia within the past year, abnormal electrocardiogram (ECG) with evidence of ischemia or arrhythmia, history or symptoms of congestive heart failure
- Uncontrolled hypertension
- History or active liver or renal disease (AST or ALT >2x upper limits of normal, calculated glomerular filtration rate [eGFR] <60 at screening)
- History of pituitary or adrenal disorders or neuroendocrine tumor
- Anemia defined as hematocrit <33% at screening
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 |
|---|---|---|
| Synthetic human AGSynthetic human AG (0.28 μg/kg) bolus over 1 minute followed by 2 μg/kg/hr continuous infusion for 4.5 hours. | Drug | Control Group, Study Group: Type 2 Diabetes Mellitus (T2DM) |
| ArginineArginine hydrochloride (5 g) intravenously over 45 seconds. | Drug | Control Group, Study Group: Type 2 Diabetes Mellitus (T2DM) |
| 0.9% saline solutionA continuous infusion of 0.9% saline solution (control) for 4.5 hours. | Drug | Control Group, Study Group: Type 2 Diabetes Mellitus (T2DM) |
Primary outcome
Postprandial insulin secretion (ISR-meal)
Time frame: approximately 8 weeks
Postprandial insulin secretion (ISR-meal) will be derived from plasma C-peptide concentrations during MTT (0-240 min) using deconvolution with population estimates of C-peptide clearance.
Index of β-cell sensitivity to glucose
Time frame: approximately 8 weeks
Index of β-cell sensitivity to glucose will be calculated as incremental insulin/glucose (I/G) AUC (ΔAUCI/G).
Whole body insulin sensitivity using the Matsuda Index
Time frame: approximately 8 weeks
The Matsuda Index is a well-known index of insulin sensitivity derived from several glucose and insulin values obtained during a mixed meal
β-cell function (DI-meal)
Time frame: approximately 8 weeks
β-cell function (DI-meal) will be calculated as ΔAUCI/G x Matsuda Index
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
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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.
Jenny Tong, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Synthetic human AG, Arginine and 0.9% saline solution in people with Type 2 Diabetes Mellitus, run by Jenny Tong, MD, MPH 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 9 inclusion and 12 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: withdrawn, as of the sponsor's last update on 2 Apr 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Postprandial insulin secretion (ISR-meal) (time frame: approximately 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2018.