Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 11 of 11

List	Outcome	Time frame	Description
Primary	Treatment Failure (Loss of Glycemic Control)	Study duration - 2 years to 6.5 years of follow up from randomization	Defined as A1c persistently \>=8% over a 6-month period or persistent metabolic decompensation (inability to wean insulin within 3 months of initiation or the occurrence of a second episode within three months of discontinuing insulin)
Secondary	Insulin Sensitivity	24 months	All participants were followed to 24 months. Insulin sensitivity is measured from OGTT as inverse of fasting insulin (mL/uU). The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.
Secondary	Number of Serious Adverse Events	Reported as occurred during study follow-up - 2 years to 6.5 years from randomization.	Number of serious adverse events reported during the trial. Participant could have multiple episodes reported.
Secondary	Insulin Secretion	24 months	Insulinogenic index determined from OGTT as difference in insulin at 30 minutes minus 0 minutes divided by difference in glucose at 30 minutes minus 0 minutes. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.
Secondary	Body Composition -- BMI	24 months	Body mass index (BMI) measured in kg per meters squared. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.
Secondary	Body Composition -- Waist Circumference	24 months	Waist circumference (cm) measured at the iliac crest at its outermost point with the measuring tape placed around the participant in a horizontal plane parallel to the floor at the mark and the measurement teken at the end of normal expiration without the tape compressing the skin. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.
Secondary	Body Composition -- Bone Density	24 months	Measured by DXA, both whole body scan and AP-spine scan. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time. In addition, in about 1/3 of participants DXA scans could not be obtained on participants weighing more than 300 pounds (136 kg), the upper limit in size set by the machine manufacturers. Scans were considered invalid if a body part (e.g., arm, leg) was completely off or partially off the scanner, there was hand-hip overlap, or there was motion or movement during the scan.
Secondary	Body Composition -- Fat Mass	24 months	Determined by DXA whole body scan. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time. In addition, in about 1/3 of participants DXA scans could not be obtained on participants weighing more than 300 pounds (136 kg), the upper limit in size set by the machine manufacturers. Scans were considered invalid if a body part (e.g., arm, leg) was completely off or partially off the scanner, there was hand-hip overlap, or there was motion or movement during the scan.
Secondary	Comorbidity -- Hypertension	Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.	A diagnosis was made by an out-of-range value \>=95th percentile or systolic \>=130 or diastolic \>=80 sustained over 6 months or on an anti-hypertensive medication.
Secondary	Comorbidity -- LDL Dyslipidemia	Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.	A diagnosis was made from out-of-range value \>= 130 mg/dL sustained over 6 months or put on lipid lowering medication.
Secondary	Comorbidity -- Triglycerides Dyslipidemia	Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.	A diagnosis was made by an out-of-range value \>=150 mg/dL sustained over 6 months or on appropriate lipid lowering medication.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this list from software.

Twenty rows a page, as JSON. No key.

GET https://conductscience.org/api/trials/v1/NCT00081328/registered

API reference For AI assistants