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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK079974 | U.S. NIH Grant/Contract | View source | |
| R01DK069861 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lean Diabetes Subjects | N=20 subjects with BMI 16-22.5 kg/m2, with a history of low birth weight and malnutrition documented on at least one occasion. Will undergo pancreatic clamp. |
| |
| Type 2 Diabetes Mellitus Subjects | N=13 subjects with BMI 22.5-27 kg/m2. Will undergo pancreatic clamp |
| |
| Type 1 Diabetes Mellitus Subjects | N=15 subjects with BMI 16-22.5 kg/m2. Will undergo pancreatic clamp |
| |
| Lean Nondiabetic Subjects | N=16 nondiabetic with BMI 16-22.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the lean DM group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp | ||
| Obese Nondiabetic Subjects | N=9 nondiabetic with BMI 16-22.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the Type 2 diabetes Mellitus group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pancreatic Clamp | Drug | We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care. |
| Measure | Description | Time Frame |
|---|---|---|
| Endogenous Glucose Production | Measurements of Endogenous glucose production in each group during the low phase of the pancreatic clamp study. | 120 min to 240 min |
| Rate of Glucose Disposal (RD). | 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. | 240 min to 360 min |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Secretion | 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. | 0 min to 120 min |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Meredith Hawkins | Albert Einstein College of Medicine | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lean Diabetes Subjects | N=20 subjects with BMI 16-19.5 kg/m2, with a history of low birth weight and malnutrition documented on at least one occasion. Will undergo pancreatic clamp. Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care. |
| FG001 | Type 2 Diabetes Mellitus Subjects | N=13 subjects with BMI 22.5-27 kg/m2. Will undergo pancreatic clamp Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care. |
| FG002 | Type 1 Diabetes Mellitus Subjects | N=15 subjects with BMI 16-22.5 kg/m2. Will undergo pancreatic clamp Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care. |
| FG003 | Lean Nondiabetic Subjects | N=16 nondiabetic with BMI 16-22.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the lean DM group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care. |
| FG004 | Obese Nondiabetic Subjects | N=9 nondiabetic with BMI 24.5-29.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the Type 2 Diabetes Mellitus group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lean Diabetes Subjects | N=20 subjects with BMI 16-22.5 kg/m2, with a history of low birth weight and malnutrition documented on at least one occasion. Will undergo pancreatic clamp. Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Endogenous Glucose Production | Measurements of Endogenous glucose production in each group during the low phase of the pancreatic clamp study. | Posted | Mean | Standard Error | mg/kg/min | 120 min to 240 min |
|
Through study completion, an average of 1 month.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Type 2 Diabetes Mellitus Subjects | N=13 subjects with BMI 22.5-27 kg/m2. Will undergo pancreatic clamp Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Meredith Hawkins | Albert Einstein College of Medicine | 718.430.3186 | meredith.hawkins@einsteinmed.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2017 | Aug 17, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D003250 | Constriction |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Plasma, Fat Biopsy
|
| BG001 | Type 2 Diabetes Mellitus Subjects | N=13 subjects with BMI 22.5-27 kg/m2. Will undergo pancreatic clamp Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care. |
| BG002 | Type 1 Diabetes Mellitus Subjects | N=15 subjects with BMI 16-22.5 kg/m2. Will undergo pancreatic clamp Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care. |
| BG003 | Lean Nondiabetic Subjects | N=16 nondiabetic with BMI 16-22.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the lean DM group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp |
| BG004 | Obese Nondiabetic Subjects | N=9 nondiabetic with BMI 16-22.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the Type 2 diabetes Mellitus group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race: for consistency, all subjects will be South Indian | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG002 | Type 1 Diabetes Mellitus Subjects | N=15 subjects with BMI 16-22.5 kg/m2. Will undergo pancreatic clamp Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care. |
| OG003 | Lean Nondiabetic Subjects | N=16 nondiabetic with BMI 16-22.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the lean DM group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care. |
| OG004 | Obese Nondiabetic Subjects | N=9 nondiabetic with BMI 24.5-29.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the Type 2 Diabetes Mellitus group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care. |
|
|
| Primary | Rate of Glucose Disposal (RD). | 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. | Posted | Mean | Standard Error | mg/kg/min | 240 min to 360 min |
|
|
|
| Secondary | Insulin Secretion | 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. | Posted | Median | Inter-Quartile Range | mg/kg/min | 0 min to 120 min |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Lean Diabetes Subjects | N=20 subjects with BMI 16-19.5 kg/m2, with a history of low birth weight and malnutrition documented on at least one occasion. Will undergo pancreatic clamp. Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Type 1 Diabetes Mellitus Subjects | N=15 subjects with BMI 16-22.5 kg/m2. Will undergo pancreatic clamp Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG003 | Lean Nondiabetic Subjects | N=16 nondiabetic with BMI 16-22.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the lean DM group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care. | 0 | 16 | 0 | 16 | 0 | 16 |
| EG004 | Obese Nondiabetic Subjects | N=9 nondiabetic with BMI 24.5-29.5 kg/m2 subjects 19-45 years of age and in general good health, taking no medications, with normal glucose tolerance and no family history of diabetes. These subjects will be similar in age, ethnicity and BMI with the Type 2 Diabetes Mellitus group, and will be recruited through various means of community outreach, including notices in shops and newspapers. Will undergo pancreatic clamp Pancreatic Clamp: We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care. | 0 | 9 | 0 | 9 | 0 | 9 |
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| D004700 | Endocrine System Diseases |