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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02987335
• Other study ID #: 2013-2191
• Secondary ID: R01DK079974R01DK
• Status: Completed
• Start date: December 2010
• Est. completion date: December 2017

Study information

• Verified date: November 2022
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Malnutrition
• Malnutrition; Diabetes

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
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.	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.	0 min to 120 min