Brief Summary
This purpose of this study is to define the metabolic characteristics of individuals with Lean Diabetes. We aim to determine whether differences in body composition, including any differences in lipid (fat) deposition, exist compared to individuals with either known forms of diabetes (eg, type 1 and type 2), or individuals without diabetes. Diabetes affects the ability of the body to process glucose (sugar). Therefore, we also plan to investigate the ability of the hormone insulin to regulate changes in glucose in these individuals. Developing a greater understanding of the features of this condition could have tremendous therapeutic benefit for these individuals.
Brief Title
Metabolic Characteristics of Lean Diabetes in Rural and Semi-urban India and in the United States
Detailed Description
India has the world's highest prevalence of diabetes, expected to rise to 80 million by 2030. This includes many patients with Lean Diabetes, which is a form of diabetes identified clinically by early onset, high insulin requirements, absence of other pancreatic disease, and low body mass index (typically ≤17 kg/m2) at presentation. Despite its prevalence, Lean Diabetes remains a relatively unknown disease that stirs conflicting opinions regarding its classification, diagnostic criteria, and pathogenesis.
In this study, the investigators will study individuals meeting the criteria for Lean Diabetes, Type 1 diabetes, Type 2 diabetes, and two group of participants without diabetes using a procedure called a "pancreatic clamp" study. During the clamp procedure, glucose (a sugar) and insulin (a hormone produced in the pancreas that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism. Endogenous glucose production (a measure of the body's production of sugar) will also be measured. Participants will also have a fat biopsy, and will be given a mixed meal challenge which is a test that detects hyperglycemia and glucose intolerance.
The overall goal of this study is to define the metabolic characteristics of individuals with Lean Diabetes and to determine which differences exist compared to individuals with other known forms of diabetes or individuals without diabetes.
In this study, the investigators will study individuals meeting the criteria for Lean Diabetes, Type 1 diabetes, Type 2 diabetes, and two group of participants without diabetes using a procedure called a "pancreatic clamp" study. During the clamp procedure, glucose (a sugar) and insulin (a hormone produced in the pancreas that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism. Endogenous glucose production (a measure of the body's production of sugar) will also be measured. Participants will also have a fat biopsy, and will be given a mixed meal challenge which is a test that detects hyperglycemia and glucose intolerance.
The overall goal of this study is to define the metabolic characteristics of individuals with Lean Diabetes and to determine which differences exist compared to individuals with other known forms of diabetes or individuals without diabetes.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Malnutrition; Diabetes
Diabetes
Eligibility Criteria
Inclusion Criteria:
* Age 19-45 yr
* Diabetes duration at least one year (for the diabetes groups)
* BMI range: 16-22.5 kg/m2 (individuals with lean and type 1 diabetes and non-diabetic controls); 22.5-27 kg/m2 in individuals with type 2 diabetes
* Negative GAD antibodies
* Present (\>1.0pmol/l) C-peptide response to Sustacal challenge
* Stable and moderate-to-poor glycemic control (HbA1c greater than 8%)
* Able and willing to provide informed consent.
Exclusion Criteria:
* Mentally disabled persons
* Major psychiatric disorder on medication (excluding successfully treated depression)
* HIV/AIDS
* History of any cancer
* Alcohol or substance abuse or toxin exposure which could be associated with neuropathy
* Cushing's syndrome
* Pregnancy or breast-feeding
* Untreated or uncontrolled hypertension
* Any Chronic illness requiring medication
* History of bleeding disorder or with a prolonged PT or PTT
* Renal disease
* Liver impairment
* Prisoners
* Age 19-45 yr
* Diabetes duration at least one year (for the diabetes groups)
* BMI range: 16-22.5 kg/m2 (individuals with lean and type 1 diabetes and non-diabetic controls); 22.5-27 kg/m2 in individuals with type 2 diabetes
* Negative GAD antibodies
* Present (\>1.0pmol/l) C-peptide response to Sustacal challenge
* Stable and moderate-to-poor glycemic control (HbA1c greater than 8%)
* Able and willing to provide informed consent.
Exclusion Criteria:
* Mentally disabled persons
* Major psychiatric disorder on medication (excluding successfully treated depression)
* HIV/AIDS
* History of any cancer
* Alcohol or substance abuse or toxin exposure which could be associated with neuropathy
* Cushing's syndrome
* Pregnancy or breast-feeding
* Untreated or uncontrolled hypertension
* Any Chronic illness requiring medication
* History of bleeding disorder or with a prolonged PT or PTT
* Renal disease
* Liver impairment
* Prisoners
Inclusion Criteria
Inclusion Criteria:
* Age 19-45 yr
* Diabetes duration at least one year (for the diabetes groups)
* BMI range: 16-22.5 kg/m2 (individuals with lean and type 1 diabetes and non-diabetic controls); 22.5-27 kg/m2 in individuals with type 2 diabetes
* Negative GAD antibodies
* Present (\>1.0pmol/l) C-peptide response to Sustacal challenge
* Stable and moderate-to-poor glycemic control (HbA1c greater than 8%)
* Able and willing to provide informed consent.
* Age 19-45 yr
* Diabetes duration at least one year (for the diabetes groups)
* BMI range: 16-22.5 kg/m2 (individuals with lean and type 1 diabetes and non-diabetic controls); 22.5-27 kg/m2 in individuals with type 2 diabetes
* Negative GAD antibodies
* Present (\>1.0pmol/l) C-peptide response to Sustacal challenge
* Stable and moderate-to-poor glycemic control (HbA1c greater than 8%)
* Able and willing to provide informed consent.
Gender
All
Gender Based
false
Keywords
Diabetes
Malnutrition
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
45 Years
Minimum Age
19 Years
NCT Id
NCT02987335
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2013-2191
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Metabolic Characteristics of Lean Diabetes in Rural and Semi-urban India and in the United States
Primary Outcomes
Outcome Description
Measurements of Endogenous glucose production in each group during the low phase of the pancreatic clamp study.
Outcome Measure
Endogenous Glucose Production
Outcome Time Frame
120 min to 240 min
Outcome Description
Peripheral Insulin Sensitivity (RD) measured by the change in Glucose Rates of Disappearance in each group during the low phase of the pancreatic clamp study.
Outcome Measure
Rate of Glucose Disposal (RD).
Outcome Time Frame
240 min to 360 min
Secondary Ids
Secondary Id
R01DK079974
Secondary Id
R01DK069861
Secondary Outcomes
Outcome Description
Insulin secretion assessed during a 120min mixed-meal tolerance test (MMTT). Insulin secretion was calculated from the C-peptide deconvolution studies with measurements mg/kg/min using the trapezoidal method.
Outcome Time Frame
0 min to 120 min
Outcome Measure
Insulin Secretion
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Subjects will be recruited from the community and outpatient practices in India. Diabetes subjects must meet the following criteria: Age 19-45 years, diabetes duration at least one year, negative GAD antibodies, \>1.0pmol/l C-peptide response to meal, stable and moderate glycemic control (HbA1c 8-11%), no pancreatic calcification, and not suffering from complications. Subjects will be otherwise in good health. Non diabetic subjects (ND): BMI 16-22.5kg/m2 (lean ND) and BMI 24.5-29.5 (obese ND), Age 19-45 years and in general good health, and no family diabetic history. Subjects will be recruited through various means of community outreach.
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
45
Minimum Age Number (converted to Years and rounded down)
19
Investigators
Investigator Type
Principal Investigator
Investigator Name
Meredith Hawkins
Investigator Email
meredith.hawkins@einsteinmed.org
Investigator Phone
718-430-3186