Trial Outcomes & Findings for Metabolic Characteristics of Lean Diabetes in Rural and Semi-urban India and in the United States (NCT NCT02987335)

NCT ID: NCT02987335

Last Updated: 2022-12-06

Results Overview

Measurements of Endogenous glucose production in each group during the low phase of the pancreatic clamp study.

Recruitment status

COMPLETED

Target enrollment

100 participants

Primary outcome timeframe

120 min to 240 min

Results posted on

2022-12-06

Participant Flow

Participant milestones

Participant milestones
Measure	Lean Diabetes Subjects N=20 subjects with BMI 16-19.5 kg/m2, with a history of low birth weight and malnutrition documented on at least one occasion. Will undergo pancreatic clamp. 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.	Type 2 Diabetes Mellitus Subjects N=13 subjects with BMI 22.5-27 kg/m2. Will undergo pancreatic clamp 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.	Type 1 Diabetes Mellitus Subjects N=15 subjects with BMI 16-22.5 kg/m2. Will undergo pancreatic clamp 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.	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 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.	Obese Nondiabetic Subjects N=9 nondiabetic with BMI 24.5-29.5 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 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.
Overall Study STARTED	20	13	15	16	9
Overall Study COMPLETED	20	13	15	16	9
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lean Diabetes Subjects n=20 Participants 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. 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.	Type 2 Diabetes Mellitus Subjects n=13 Participants N=13 subjects with BMI 22.5-27 kg/m2. Will undergo pancreatic clamp 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.	Type 1 Diabetes Mellitus Subjects n=15 Participants N=15 subjects with BMI 16-22.5 kg/m2. Will undergo pancreatic clamp 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.	Lean Nondiabetic Subjects n=16 Participants 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 Participants 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	Total n=73 Participants Total of all reporting groups
Age, Continuous	41.5 years n=99 Participants	36.2 years n=107 Participants	28.0 years n=206 Participants	26.0 years n=7 Participants	41.0 years n=31 Participants	33.5 years n=30 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Sex: Female, Male Male	20 Participants n=99 Participants	13 Participants n=107 Participants	15 Participants n=206 Participants	16 Participants n=7 Participants	9 Participants n=31 Participants	73 Participants n=30 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=99 Participants	13 Participants n=107 Participants	15 Participants n=206 Participants	16 Participants n=7 Participants	9 Participants n=31 Participants	73 Participants n=30 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Asian	20 Participants n=99 Participants	13 Participants n=107 Participants	15 Participants n=206 Participants	16 Participants n=7 Participants	9 Participants n=31 Participants	73 Participants n=30 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants
Region of Enrollment India	20 participants n=99 Participants	13 participants n=107 Participants	15 participants n=206 Participants	16 participants n=7 Participants	9 participants n=31 Participants	73 participants n=30 Participants
BMI	18.3 kg/m^2 STANDARD_DEVIATION 0.2 • n=99 Participants	26.0 kg/m^2 STANDARD_DEVIATION 0.3 • n=107 Participants	20.5 kg/m^2 STANDARD_DEVIATION 0.4 • n=206 Participants	19.1 kg/m^2 STANDARD_DEVIATION 0.6 • n=7 Participants	25.4 kg/m^2 STANDARD_DEVIATION 0.35 • n=31 Participants	22.1 kg/m^2 STANDARD_DEVIATION 0.2 • n=30 Participants

PRIMARY outcome

Timeframe: 120 min to 240 min

Measurements of Endogenous glucose production in each group during the low phase of the pancreatic clamp study.

Outcome measures

Outcome measures
Measure	Lean Diabetes Subjects n=20 Participants N=20 subjects with BMI 16-19.5 kg/m2, with a history of low birth weight and malnutrition documented on at least one occasion. Will undergo pancreatic clamp. 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.	Type 2 Diabetes Mellitus Subjects n=13 Participants N=13 subjects with BMI 22.5-27 kg/m2. Will undergo pancreatic clamp 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.	Type 1 Diabetes Mellitus Subjects n=15 Participants N=15 subjects with BMI 16-22.5 kg/m2. Will undergo pancreatic clamp 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.	Lean Nondiabetic Subjects n=16 Participants 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 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.	Obese Nondiabetic Subjects n=9 Participants N=9 nondiabetic with BMI 24.5-29.5 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 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.
Endogenous Glucose Production	0.5 mg/kg/min Standard Error 0.1	0.84 mg/kg/min Standard Error 0.1	0.6 mg/kg/min Standard Error 0.1	0.4 mg/kg/min Standard Error 0.1	0.7 mg/kg/min Standard Error 0.1

PRIMARY outcome

Timeframe: 240 min to 360 min

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.

Outcome measures

Outcome measures
Measure	Lean Diabetes Subjects n=20 Participants N=20 subjects with BMI 16-19.5 kg/m2, with a history of low birth weight and malnutrition documented on at least one occasion. Will undergo pancreatic clamp. 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.	Type 2 Diabetes Mellitus Subjects n=13 Participants N=13 subjects with BMI 22.5-27 kg/m2. Will undergo pancreatic clamp 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.	Type 1 Diabetes Mellitus Subjects n=15 Participants N=15 subjects with BMI 16-22.5 kg/m2. Will undergo pancreatic clamp 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.	Lean Nondiabetic Subjects n=16 Participants 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 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.	Obese Nondiabetic Subjects n=9 Participants N=9 nondiabetic with BMI 24.5-29.5 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 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.
Rate of Glucose Disposal (RD).	10.1 mg/kg/min Standard Error 0.7	4.2 mg/kg/min Standard Error 0.5	8.5 mg/kg/min Standard Error 0.4	10.8 mg/kg/min Standard Error 0.7	7.6 mg/kg/min Standard Error 0.5

SECONDARY outcome

Timeframe: 0 min to 120 min

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.