Ghrelin and Beta Cell Function in Diabetes
| Status: | Withdrawn |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/17/2018 |
| Start Date: | May 2018 |
| End Date: | June 2019 |
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.
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.
Inclusion Criteria:
T2DM study subjects to be considered for the study must meet the following inclusion
criteria:
1. Established T2DM with good to moderate glycemic control
2. HbA1c < 8.5%
3. Diabetes treatment with metformin, sulfonylurea, thiazolidinediones or combination of
these medications; with no use of insulin during the study period
4. 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:
1. HbA1c ≤ 5.7%
2. Fasting plasma glucose ≤ 95 mg/dL
3. BMI ≤ 45.0 kg/m2
Exclusion Criteria:
All subjects will be excluded for the following reasons:
1. 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
2. Uncontrolled hypertension
3. History or active liver or renal disease (AST or ALT >2x upper limits of normal,
calculated glomerular filtration rate [eGFR] <60 at screening)
4. History of pituitary or adrenal disorders or neuroendocrine tumor
5. Anemia defined as hematocrit <33% at screening
6. Active cancer diagnosis or currently undergoing cancer treatment
7. History of anorexia nervosa or previous gastrointestinal tract surgery
8. Pregnancy or lactation
Control subjects will be excluded for the following reasons:
1. 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
2. Use of medications that alter insulin sensitivity (i.e. niacin, glucocorticoids,
metformin)
We found this trial at
1
site
Durham, North Carolina 27710
Principal Investigator: Jenny Tong, MD
Phone: 919-660-6766
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