Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 34 of 87 for:    NIDDK endocrine and diabetes | Recruiting, Not yet recruiting, Available Studies

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02987335
Recruitment Status : Not yet recruiting
First Posted : December 8, 2016
Last Update Posted : January 21, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Meredith Hawkins, Albert Einstein College of Medicine

Brief Summary:
India has the world's highest prevalence of diabetes, expected to rise to 80 million by 2030. This includes many patients with lean diabetes, with low body mass index (BMI) and severe complications of diabetes. Despite its prevalence in India and other countries and its dire health consequences to individuals with the disease, little is known about the aetiopathogenesis and the genotype-phenotype relationship, lean diabetes being a cluster of low birth weight individuals, MODY, lipododystrophic disease, type 1 diabetes and fibrocalcific disease. While rudimentary tests have suggested defects in both insulin secretion and action, no comprehensive metabolic studies have been performed. It is therefore unclear as to how these patients should be treated. The optimal therapeutic adjunct whether a suitable oralantidiabetic agent or insulin is not yet determined. Defining the metabolic defects of 'lean' diabetes should have tremendous therapeutic benefit for millions of patients with this elusive condition.

Condition or disease Intervention/treatment
Malnutrition; Diabetes Drug: Pancreatic Clamp

Detailed Description:
These studies will define the body composition and metabolic features of lean diabetes and enable us to explore a novel frontier in the intriguing dynamic between fat metabolism and insulin sensitivity.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Metabolic Characteristics of Lean Diabetes in Rural and Semi-urban India and in the United States
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Group/Cohort Intervention/treatment
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
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 Name: Clamp

Type 2 Diabetes Mellitus Subjects
N=20 subjects with BMI 22.5-27 kg/m2. Will undergo pancreatic clamp
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.
Other Name: Clamp

Type 1 Diabetes Mellitus Subjects
N=20 subjects with BMI 16-22.5 kg/m2. Will undergo pancreatic clamp
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.
Other Name: Clamp

Nondiabetic Subjects
N=20 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
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.
Other Name: Clamp




Primary Outcome Measures :
  1. Plasma insulin [ Time Frame: 0 min to 360 min ]
    Measurements of plasma insulin, C-peptide, glucagon, and GH are taken throughout the study in order to evaluate the adequacy of the pancreatic clamp technique, i.e. the inhibitory effects of somatostatin on hormone secretion and the uniformity of hormone replacement.

  2. C-peptide [ Time Frame: 0 min to 360 min ]
    Measurements of plasma insulin, C-peptide, glucagon, and GH are taken throughout the study in order to evaluate the adequacy of the pancreatic clamp technique, i.e. the inhibitory effects of somatostatin on hormone secretion and the uniformity of hormone replacement.

  3. Glucagon [ Time Frame: 0 min to 360 min ]
    Measurements of plasma insulin, C-peptide, glucagon, and GH are taken throughout the study in order to evaluate the adequacy of the pancreatic clamp technique, i.e. the inhibitory effects of somatostatin on hormone secretion and the uniformity of hormone replacement.

  4. Growth Hormone [ Time Frame: 0 min to 360 min ]
    Measurements of plasma insulin, C-peptide, glucagon, and GH are taken throughout the study in order to evaluate the adequacy of the pancreatic clamp technique, i.e. the inhibitory effects of somatostatin on hormone secretion and the uniformity of hormone replacement.


Biospecimen Retention:   Samples Without DNA
Plasma, Fat Biopsy


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects with diabetes will be recruited from the community and outpatient diabetes practices at CMC India, Jacobi Medical Center, and North Central Bronx hospital. These subjects will meet the following criteria: Age 19-45 years, diabetes duration at least one year, negative GAD antibodies, >1.0 pmol/l C-peptide response to Sustacal challenge, stable and moderate-to-poor glycemic control (HbA1c between 8-11%), no pancreatic calcification on imaging, and not suffering from significant complications. Diabetic subjects will be otherwise in good health.

Subjects without diabetes: BMI 16-22.5 kg/m2, Age 19-45 years and in general good health, taking no medications, normal glucose tolerance, and no family history of diabetes. 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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02987335


Contacts
Layout table for location contacts
Contact: Tiffany Cheng 718-430-2903 tiffany.cheng@einstein.yu.edu
Contact: Mohammad Aldabagh 718-430-2903 mohammad.aldabagh@einstein.yu.edu

Sponsors and Collaborators
Albert Einstein College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: Meredith Hawkins Albert Einstein College of Medicine

Layout table for additonal information
Responsible Party: Meredith Hawkins, Professor of Medicine, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT02987335     History of Changes
Other Study ID Numbers: 2013-2191
R01DK079974 ( U.S. NIH Grant/Contract )
R01DK069861 ( U.S. NIH Grant/Contract )
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Malnutrition
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nutrition Disorders