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Beta Cell Restoration Through Fat Mitigation (BetaFat)

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ClinicalTrials.gov Identifier: NCT01763346
Recruitment Status : Completed
First Posted : January 8, 2013
Results First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Thomas Buchanan, University of Southern California

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Prediabetes
Type 2 Diabetes
Obesity
Interventions Drug: Metformin
Device: gastric banding
Enrollment 88
Recruitment Details Recruited from Kaiser Permanente Southern California
Pre-assignment Details Five participants randomized to metformin and six participants randomized to gastric banding refused to initiate treatment
Arm/Group Title Metformin Gastric Banding
Hide Arm/Group Description

subjects receiving metformin

Metformin: metformin 1000 mg bid

subjects receiving LAP-BAND

gastric banding: LAP-BAND

Period Title: Overall Study
Started 44 [1] 44 [2]
Received Intervention 39 38
Completed 34 36
Not Completed 10 8
[1]
Five subjects who enrolled in the study refused to initiate metformin therapy, thus did not "start"
[2]
Six subjects randomized to gastric banding refused the banding surgery and, thus, did not "start"
Arm/Group Title Metformin Gastric Banding Total
Hide Arm/Group Description

subjects receiving metformin

Metformin: metformin 1000 mg bid

subjects receiving LAP-BAND

gastric banding: LAP-BAND

Total of all reporting groups
Overall Number of Baseline Participants 44 44 88
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
44
 100.0%
44
 100.0%
88
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
Female
34
  77.3%
35
  79.5%
69
  78.4%
Male
10
  22.7%
9
  20.5%
19
  21.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
Hispanic or Latino
21
  47.7%
19
  43.2%
40
  45.5%
Not Hispanic or Latino
23
  52.3%
25
  56.8%
48
  54.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   9.1%
3
   6.8%
7
   8.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
  20.5%
7
  15.9%
16
  18.2%
White
31
  70.5%
34
  77.3%
65
  73.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 44 participants 44 participants 88 participants
44 44 88
Hyperglycemic clamp   [1] 
Geometric Mean (Inter-Quartile Range)
Unit of measure:  Nmol/l adjusted for insulin sensitivity
Number Analyzed 44 participants 44 participants 88 participants
3.37
(2.71 to 3.35)
3.67
(3.28 to 4.1)
3.52
(2.99 to 3.74)
[1]
Measure Description: data are reported as gemetric mean and 95% confidence interval
Oral Glucose Tolerance Test  
Mean (Standard Deviation)
Unit of measure:  Mmol/l
Number Analyzed 44 participants 44 participants 88 participants
fasting glucose 6.2  (0.8) 6.2  (0.7) 6.2  (0.75)
2-hour glucose 10.5  (2.6) 10.4  (2.7) 10.45  (2.65)
Body weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 44 participants 44 participants 88 participants
96.1  (10.9) 97.5  (12.2) 96.8  (11.8)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kilograms per meters squared
Number Analyzed 44 participants 44 participants 88 participants
35.0  (2.9) 35.7  (2.9) 35.53  (2.9)
Hemoglobin A1C   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent of hemoglobin
Number Analyzed 44 participants 44 participants 88 participants
5.82  (0.06) 5.92  (0.06) 5.87  (0.06)
[1]
Measure Description: values are given as standard error and not standard deviation
1.Primary Outcome
Title Steady State Beta Cell Compensation
Hide Description mean plasma C-peptide concentration during clamp steady state, adjusted for mean clamp insulin sensitivity
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants completing 24-month hyperglycemic clamp
Arm/Group Title Metformin Gastric Banding
Hide Arm/Group Description:

subjects receiving metformin

Metformin: metformin 1000 mg bid

subjects receiving LAP-BAND

gastric banding: LAP-BAND

Overall Number of Participants Analyzed 34 36
Geometric Mean (95% Confidence Interval)
Unit of Measure: (nmol/L) adjusted for M/I
3.01
(2.71 to 3.35)
3.19
(2.88 to 3.53)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Metformin, Gastric Banding
Comments We selected a sample size that would allow detection of an effect size of ~0.6 or greater between gastric band and metformin groups for measures of β-cell function after two years, hypothesizing greater function in the gastric band group.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments 35 subjects per group provided 80% power to detect an effect size of 0.59, assuming a 2-sided p=0.05, adjustment for baseline measures using ANCOVA, and correlation of 0.5 between baseline and end-study measures.
Method General Linear Models
Comments Differences in primary outcomes between groups at 24-months were compared using general linear models with baseline values included as covariates.
2.Other Pre-specified Outcome
Title Glycemia
Hide Description fasting and 2-hour OGTT glucose levels
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
participants completing 24 months of interventions
Arm/Group Title Metformin Gastric Banding
Hide Arm/Group Description:

subjects receiving metformin

Metformin: metformin 1000 mg bid

subjects receiving LAP-BAND

gastric banding: LAP-BAND

Overall Number of Participants Analyzed 34 36
Mean (Standard Error)
Unit of Measure: mmol/l
fasting glucose 5.95  (0.11) 5.85  (0.18)
2-hour glucose 10.87  (0.57) 9.92  (0.54)
3.Other Pre-specified Outcome
Title Glycemia
Hide Description HbA1C
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
participants completing 24 months of interventions
Arm/Group Title Metformin Gastric Banding
Hide Arm/Group Description:

subjects receiving metformin

Metformin: metformin 1000 mg bid

subjects receiving LAP-BAND

gastric banding: LAP-BAND

Overall Number of Participants Analyzed 34 36
Mean (Standard Error)
Unit of Measure: percent of hemoglobin
5.84  (0.09) 5.73  (0.09)
Time Frame 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metformin Gastric Banding
Hide Arm/Group Description

subjects receiving metformin

Metformin: metformin 1000 mg bid

subjects receiving LAP-BAND

gastric banding: LAP-BAND

All-Cause Mortality
Metformin Gastric Banding
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)      0/38 (0.00%)    
Hide Serious Adverse Events
Metformin Gastric Banding
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/39 (5.13%)      4/38 (10.53%)    
Gastrointestinal disorders     
gastric band slippage requiring removal  [1]  0/39 (0.00%)  0 2/38 (5.26%)  2
acalcuous cholecystitis  [2]  0/39 (0.00%)  0 1/38 (2.63%)  1
Gastric sleeve surgery  [3]  1/39 (2.56%)  1 0/38 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Ankle fracture  [4]  1/39 (2.56%)  1 0/38 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
breast cancer   0/39 (0.00%)  0 2/38 (5.26%)  2
Indicates events were collected by systematic assessment
[1]
gastric band slippage requireing removal
[2]
Requering gall bladder removal
[3]
elective
[4]
requiring fixation, resutling from traffic accident
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metformin Gastric Banding
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/39 (46.15%)      3/38 (7.89%)    
Gastrointestinal disorders     
Port revision   0/39 (0.00%)  0 2/38 (5.26%)  2
dysphagia   0/39 (0.00%)  0 1/38 (2.63%)  1
stomach pain or discomfort   11/39 (28.21%)  11 0/38 (0.00%)  0
dairrhea   3/39 (7.69%)  3 0/38 (0.00%)  0
heartburn   1/39 (2.56%)  1 0/38 (0.00%)  0
nausea   1/39 (2.56%)  1 0/38 (0.00%)  0
General disorders     
Lack of energy   1/39 (2.56%)  1 0/38 (0.00%)  0
Psychiatric disorders     
Depression   1/39 (2.56%)  1 0/38 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Thomas Buchanan
Organization: University or Southern California
Phone: 3234794319
EMail: buchanan@usc.edu
Layout table for additonal information
Responsible Party: Thomas Buchanan, University of Southern California
ClinicalTrials.gov Identifier: NCT01763346    
Other Study ID Numbers: BETAFAT
U01DK094430 ( U.S. NIH Grant/Contract )
IIT - 000395 ( Other Grant/Funding Number: Allergan Corporation )
First Submitted: January 4, 2013
First Posted: January 8, 2013
Results First Submitted: August 28, 2019
Results First Posted: October 21, 2019
Last Update Posted: October 21, 2019