Malnutrition; DiabetesNCT02987335
Metabolic Characteristics of Lean Diabetes in Rural and Semi-urban India and in the United States
An observational study of Malnutrition; Diabetes and Diabetes, run by Albert Einstein College of Medicine.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition; Diabetes, Diabetes
- What is being tested?
- Pancreatic Clamp
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Dec 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
About this study
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.
Read the 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.
- Conditions
- Malnutrition; Diabetes, Diabetes
- Being tested
- Pancreatic Clamp
- Keywords
- Diabetes, Malnutrition
- Medical subject headings
- Malnutrition, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancreatic ClampDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Pancreatic Clamp | |
| Type 2 Diabetes Mellitus Subjects | N=13 subjects with BMI 22.5-27 kg/m2. Will undergo pancreatic clamp Receives: Drug: Pancreatic Clamp | |
| Type 1 Diabetes Mellitus Subjects | N=15 subjects with BMI 16-22.5 kg/m2. Will undergo pancreatic clamp Receives: Drug: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endogenous Glucose Production
Measurements of Endogenous glucose production in each group during the low phase of the pancreatic clamp study.
Measured: 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.
Measured: 240 min to 360 min
Secondary outcomes (1)
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.
Measured: 0 min to 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startDec 2010
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malnutrition; DiabetesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meredith Hawkins, Albert Einstein College of Medicine
- Investigators
- Meredith Hawkins, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987335
- Sponsor's protocol ID
- 2013-2191
- Other IDs
- R01DK079974, R01DK069861
- Status last verified
- Nov 2022
- First submitted
- 2 Dec 2016
- Last updated
- 6 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Characteristics of Lean Diabetes in Rural and Semi-urban India and in the United States
- ClinicalTrials.gov ID
- NCT02987335
- Acronym / sponsor ID
- 2013-2191
- Conditions
- Malnutrition; Diabetes, Diabetes
- Keywords
- Diabetes, Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Dec 2010 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Posted 6 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Lean Diabetes Subjects | – | Drug: Pancreatic ClampN=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 | – | Drug: Pancreatic ClampN=13 subjects with BMI 22.5-27 kg/m2. Will undergo pancreatic clamp |
| Type 1 Diabetes Mellitus Subjects | – | Drug: Pancreatic ClampN=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 |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Pancreatic ClampAlso: ClampWe 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. | Drug | Lean Diabetes Subjects, Type 1 Diabetes Mellitus Subjects, Type 2 Diabetes Mellitus Subjects |
Primary outcome
Endogenous Glucose Production
Time frame: 120 min to 240 min
Measurements of Endogenous glucose production in each group during the low phase of the pancreatic clamp study.
Rate of Glucose Disposal (RD).
Time frame: 240 min to 360 min
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.
1 secondary outcome
Insulin Secretion
Time frame: 0 min to 120 min
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Malnutrition; Diabetes
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Effects of Increased Water Intake on Hormonal Response, Hydration Status, and Physical Function in Low-drinking Older Adults
Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
Not yet recruitingObservational study
Nutritional Status in Adults With Diabetic Foot Ulcers
Diabetic Foot Ulcers (DFU), Nutrition Assessment
Active, not recruitingObservational study
Local and Systemic Inflammatory Bone Alterations Related to Dental Implant Survival.
Peri Implant Mucositis, Peri Implant Bone Loss
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.
Meredith Hawkins principal investigator
Albert Einstein College of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition; Diabetes and Diabetes, run by Albert Einstein College of Medicine.
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 7 inclusion and 13 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: finished, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Endogenous Glucose Production (time frame: 120 min to 240 min). The study lists 2 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 6 Dec 2022.