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

NCT02987335 | Completed Results DMC FDA Drug

• 3 other identifiers: 2013-2191R01DK079974R01DK069861
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malnutrition; Diabetes; Diabetes

Keywords

Diabetes; Malnutrition

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Insulin Secretion

  0 min to 120 min

Study Arms (5)

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.

Drug: Pancreatic Clamp

Type 2 Diabetes Mellitus Subjects

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

Drug: Pancreatic Clamp

Type 1 Diabetes Mellitus Subjects

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

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

Interventions

Pancreatic Clamp 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.

Also known as: Clamp

Lean Diabetes Subjects; Type 1 Diabetes Mellitus Subjects; Type 2 Diabetes Mellitus Subjects

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, Fat Biopsy

MeSH Terms

Conditions

Malnutrition; Diabetes Mellitus

Interventions

Constriction

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Dr Meredith Hawkins
• Organization: Albert Einstein College of Medicine

meredith.hawkins@einsteinmed.org

718.430.3186

Study Officials

• Meredith Hawkins

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 8, 2016
• Study Start: December 1, 2010
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 6, 2022
• Results First Posted: December 6, 2022

Record last verified: 2022-11