Trial · NCT01763346

Beta Cell Restoration Through Fat Mitigation

NCT01763346, Not applicable, Completed, University of Southern California; results first posted 2019-10-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Beta Cell Restoration Through Fat Mitigation. Trials, record NCT01763346. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01763346

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Beta Cell Restoration Through Fat Mitigation
NCT number: NCT01763346
Status: Completed
Phases: Not applicable
Enrollment: 88 participants, actual
Lead sponsor: University of Southern California
Conditions: Prediabetes, Type 2 Diabetes, Obesity
Interventions: Metformin, gastric banding
First posted: 2013-01-08
Last updated: 2019-10-21
Results first posted: 2019-10-21

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Steady State Beta Cell Compensation	24 months	mean plasma C-peptide concentration during clamp steady state, adjusted for mean clamp insulin sensitivity
Other	Glycemia	24 months	fasting and 2-hour OGTT glucose levels
Other	Glycemia	24 months	HbA1C

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Steady State Beta Cell Compensation	24 months	Participants completing 24-month hyperglycemic clamp	(nmol/L) adjusted for M/I	GEOMETRIC_MEAN
OTHER_PRE_SPECIFIED	Glycemia	24 months	participants completing 24 months of interventions	mmol/l	MEAN
OTHER_PRE_SPECIFIED	Glycemia	24 months	participants completing 24 months of interventions	percent of hemoglobin	MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Steady State Beta Cell Compensation	Metformin		3.01	95% Confidence Interval 2.71 to 3.35	(nmol/L) adjusted for M/I
Steady State Beta Cell Compensation	Gastric Banding		3.19	95% Confidence Interval 2.88 to 3.53	(nmol/L) adjusted for M/I
Glycemia	Metformin	fasting glucose	5.95	Standard Error 0.11	mmol/l
Glycemia	Gastric Banding	fasting glucose	5.85	Standard Error 0.18	mmol/l
Glycemia	Metformin	2-hour glucose	10.87	Standard Error 0.57	mmol/l
Glycemia	Gastric Banding	2-hour glucose	9.92	Standard Error 0.54	mmol/l
Glycemia	Metformin		5.84	Standard Error 0.09	percent of hemoglobin
Glycemia	Gastric Banding		5.73	Standard Error 0.09	percent of hemoglobin

Source ClinicalTrials.gov

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Metformin	44
Overall Study	STARTED	Gastric Banding	44
Overall Study	Received Intervention	Metformin	39
Overall Study	Received Intervention	Gastric Banding	38
Overall Study	COMPLETED	Metformin	34
Overall Study	COMPLETED	Gastric Banding	36
Overall Study	NOT COMPLETED	Metformin	10
Overall Study	NOT COMPLETED	Gastric Banding	8

Source ClinicalTrials.gov

Adverse events26

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Port revision	Gastrointestinal disorders	Metformin	0	39	0
other	Port revision	Gastrointestinal disorders	Gastric Banding	2	38	2
other	dysphagia	Gastrointestinal disorders	Metformin	0	39	0
other	dysphagia	Gastrointestinal disorders	Gastric Banding	1	38	1
other	stomach pain or discomfort	Gastrointestinal disorders	Metformin	11	39	11
other	stomach pain or discomfort	Gastrointestinal disorders	Gastric Banding	0	38	0
other	dairrhea	Gastrointestinal disorders	Metformin	3	39	3
other	dairrhea	Gastrointestinal disorders	Gastric Banding	0	38	0
other	Depression	Psychiatric disorders	Metformin	1	39	1
other	Depression	Psychiatric disorders	Gastric Banding	0	38	0

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Metformin	0	39
Total, all-cause mortality	Gastric Banding	0	38
Total, other adverse events	Metformin	18	39
Total, other adverse events	Gastric Banding	3	38
Total, serious adverse events	Metformin	2	39
Total, serious adverse events	Gastric Banding	4	38

Source ClinicalTrials.gov

Papers11

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24194506	BACKGROUND	PubMed
28493515	DERIVED	PubMed
29941497	RESULT	PubMed
29941498	DERIVED	PubMed
30282699	RESULT	PubMed
31301210	DERIVED	PubMed
33436401	DERIVED	PubMed
34131047	DERIVED	PubMed
34135015	DERIVED	PubMed
35894078	DERIVED	PubMed

1 to 10 of 11

See all 11 papers

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01DK094430	Beta Cell Restoration through Fat Mitigation	BUCHANAN, THOMAS A	UNIVERSITY OF SOUTHERN CALIFORNIA	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2011 to 2015

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Metformin vs Gastric Banding: deaths from any cause	Trial comparisons
Metformin vs Gastric Banding: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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 trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01763346

GET https://conductscience.org/api/trials/v1/NCT01763346/events?page=2

API reference For AI assistants