Clinical trial NCT02987335: Metabolic Characteristics of Lean Diabetes in Rural and Semi-urban India and in the United States
Official title: Metabolic Characteristics of Lean Diabetes in Rural and Semi-urban India and in the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition; Diabetes
Diabetes
Keywords: Diabetes
Malnutrition
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-12-08
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
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.

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.

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

Primary outcomes:
measure: Endogenous Glucose Production
timeFrame: 120 min to 240 min
measure: Rate of Glucose Disposal (RD).
timeFrame: 240 min to 360 min
Secondary outcomes:
measure: Insulin Secretion
timeFrame: 0 min to 120 min
Other outcomes:
Locations:
Study officials:
affiliation: Albert Einstein College of Medicine
name: Meredith Hawkins
role: PRINCIPAL_INVESTIGATOR
References: