Metabolic Characteristics of Lean Diabetes in Rural and Semi-urban India and in the United States

NCT ID: NCT02987335

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2017-12-31

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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Intervention Type: 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.

Type 2 Diabetes Mellitus Subjects

N=13 subjects with BMI 22.5-27 kg/m2. Will undergo pancreatic clamp

Pancreatic Clamp

Intervention Type: 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.

Type 1 Diabetes Mellitus Subjects

N=15 subjects with BMI 16-22.5 kg/m2. Will undergo pancreatic clamp

Pancreatic Clamp

Intervention Type: 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.

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

No interventions assigned to this group

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

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Clamp

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Meredith Hawkins

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meredith Hawkins

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01DK079974

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01DK069861

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2013-2191

Identifier Type: -

Identifier Source: org_study_id