Metabolic Characteristics of Lean Diabetes in Rural and Semi-urban India and in the United States
Condition: Malnutrition; Diabetes; Diabetes
MeSH terms: Diabetes Mellitus; Malnutrition
Study type: Observational

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.
    

Intervention name(s): Pancreatic Clamp
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): Clamp
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
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.
      
Biospecimen description: 
      Plasma, Fat Biopsy
    
Keywords: Diabetes; Malnutrition