N/A
N=73
Metabolic Characteristics of Lean Diabetes in Rural and Semi-urban India and in the United States
Malnutrition; Diabetes · Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02987335 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Endogenous Glucose Production — 0.5; 0.84; 0.6; 0.4 mg/kg/min
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Pancreatic Clamp (Drug)
- Age
- Adult · 19+ yrs
- Sex
- All
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Endogenous Glucose Production |
0.5; 0.84; 0.6; 0.4; 0.7 | — |
| PRIMARY Rate of Glucose Disposal (RD). |
10.1; 4.2; 8.5; 10.8; 7.6 | — |
| SECONDARY Insulin Secretion |
383.0; 839.5; 0.09; 591.1; 1277.0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02987335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.