No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
30 (estimated)
Sponsor
David D'Alessio, M.D. · Other
Who this trial is looking for
This trial is looking for adults aged 18-60 with diabetes or insulin resistance. Participants will help researchers understand insulin and glucose management by possibly undergoing tests and examinations.
Are You a Good Fit for This Trial?
Must not be takingGlucocorticoidsPsychotropicsNarcoticsMetoclopramide
You may be able to join if
I am between 18 and 60 years old
I have a Body Mass Index (BMI) within the specified range
I have a fasting plasma glucose or HbA1c value within the specified range
You may not be able to join if
I have an active medical disease
I have a history of diabetes or pancreatitis
I have a history of cardiac, gastrointestinal, renal or liver disease
I have a family history of diabetes
I have renal insufficiency
I have anemia
I am pregnant
I have poor vein access
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Glucagon secretion from α-cells has long been viewed as primarily a counterregulatory mechanism - e.g. an agent with a role to prevent blood sugar from decreasing to levels that compromise function. Our group, along with other researchers, have begun to identify a much more complex role for α-cells, raising questions about when and how glucagon may influence blood glucose levels. This proposal loo…
Glucagon secretion from α-cells has long been viewed as primarily a counterregulatory mechanism - e.g. an agent with a role to prevent blood sugar from decreasing to levels that compromise function. Our group, along with other researchers, have begun to identify a much more complex role for α-cells, raising questions about when and how glucagon may influence blood glucose levels. This proposal looks to detail proglucagon peptide secretion from α-cells and the impact this has on β-cell function and glucose tolerance, in preclinical studies of human islets and translational studies in human subjects. This protocol registration describes Aim 2 from this NIH grant which involves 2 study populations and separate protocols but addresses a common question. Aim 3 in the grant is focused on a separate hypothesis and will be conducted and published separately from Aim 2.
Trial Locations
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Status
Eligibility Criteria
Aim 2A and 2A sub-study: Inclusion Criteria:
* Age 18-45
* Body Mass Index (BMI) \< 27.0
* Fasting plasma glucose of ≤ 95 mg/dL or HbA1c value ≤ 5.8% as measured at screening visit
Exclusion Criteria:
* Active medical disease: e.g. active infectious, inflammatory, neurodegenerative or mental heal…
Aim 2A and 2A sub-study: Inclusion Criteria:
* Age 18-45
* Body Mass Index (BMI) \< 27.0
* Fasting plasma glucose of ≤ 95 mg/dL or HbA1c value ≤ 5.8% as measured at screening visit
Exclusion Criteria:
* Active medical disease: e.g. active infectious, inflammatory, neurodegenerative or mental health disorders
* Personal history of diabetes or pancreatitis
* Personal history of cardiac, gastrointestinal, renal or liver disease
* Immediate family history of diabetes
* Renal insufficiency (eGFR \< 60 mL/kg/min)
* Anemia (hematocrit \< 34%) as measured at screening visit
* Pregnant females
* Poor vein access
* Consumption of daily medications that alter glucose metabolism of GI function (glucocorticoids, psychotropics, narcotics, metoclopramide)
* Apparent sensitivity to the study peptide as determined by the skin test
Aim 2B: Inclusion Criteria:
* Age 35-60
* Body Mass Index (BMI) ≥ 27.0
* Fasting plasma glucose of \< 126 mg/dL or HbA1c value \< 6.5% as measured at screening visit
Exclusion Criteria:
* Active medical disease: e.g. active infectious, inflammatory, neurodegenerative or mental health disorders
* Personal history of diabetes or pancreatitis
* Personal history of cardiac, gastrointestinal, renal or liver disease
* Immediate family history of diabetes
* Renal insufficiency (eGFR \< 60 mL/kg/min)
* AST and/or ALT levels \> 3x the upper limit of the normal range
* Anemia (hematocrit \< 34%) as measured at screening visit
* Pregnant females
* Poor vein access
* Consumption of daily medications that alter glucose metabolism of GI function (glucocorticoids, psychotropics, narcotics, metoclopramide)
* Apparent sensitivity to the study peptide as determined by the skin test
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