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PrediabetesBetaFatNCT01763346

Beta Cell Restoration Through Fat Mitigation

A study testing Metformin and gastric banding in people with Prediabetes and Type 2 Diabetes, run by University of Southern California at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Weight loss achieved through gastric banding will be superior to treatment with metformin in preserving or restoring pancreatic beta cell function in people with prediabetes or mild type 2 diabetes. Read more about this study

Who is it for?
Ages 22 to 65 years
Conditions the study is for
Prediabetes, Type 2 Diabetes, Obesity
What is being tested?
Metformin and gastric banding
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteUnited States
Study dates
Jun 2013to Jun 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Prior completion of at least two months in a diet, exercise and lifestyle intervention program within the past two years
  • Fasting plasma glucose >90 mg/dl plus 2-hour glucose ≥140 mg/dl on 75 gm OGTT plus HbA1C ≤7.0%. There is no lower limit for the A1C and no upper limit for the OGTT 2-hour glucose based on prior studies that allow us to identify people with falling β-cell function
  • Age 22-65 years
  • Body mass index (BMI) 30-40 kg/m2
  • For participants with diabetes, known duration <1 year
  • No history of use of antidiabetic medications except during pregnancy

Who cannot join

  • Contraindications to LapBand(see Appendix 1)
  • Contraindication to MRI (claustrophobia; permanent metal objects such as pacemakers, prostheses, aneurysm clips)
  • Underlying disease(s) likely to (a) limit life span to less than study duration and/or (b) increase risk of intervention outside of the study and/or (c) limit ability to participate in outcomes assessment and/or (d) limit participation
  • An underlying disease known to have important effects on glucose metabolism
  • Active infections
  • Renal disease (serum creatinine ≥1.4 mg/dl for men; ≥1.3 mg/dl for women) or serum potassium abnormality (<3.4 or >5.5 mmol/l)
Show all 21Show fewer
  • Anemia (hemoglobin <11g/dl in women, <12 g/dl in men) or known coagulopathy
  • Cardiovascular disease, including uncontrolled hypertension and symptomatic congestive heart failure. Participants must be able to safely tolerate administration of fluid/volume challenges during clamp studies.
  • Serum AST >3 times upper limit of normal in local clinical lab
  • Excessive alcohol intake
  • Suboptimally treated thyroid disease
  • Conditions or behaviors likely to affect the conduct of the study
  • unable or unwilling to give informed consent
  • unable to adequately communicate with clinic staff
  • another household member is a participant or staff member
  • current or anticipated participation in another intervention research project that would interfere with any of the interventions/outcomes
  • likely to move away from participating clinic in next 2 years
  • current (or anticipated) pregnancy and lactation.
  • major psychiatric disorder that, in the opinion of clinic staff, would impede the conduct of the study
  • weight loss >5% in past three months for any reason except postpartum weight loss.
  • additional conditions may serve as criteria for exclusion at the discretion of the local site

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Southern California

    Los Angeles, California, 91011

Other trials in United States

About this study

Weight loss achieved through gastric banding will be superior to treatment with metformin in preserving or restoring pancreatic beta cell function in people with prediabetes or mild type 2 diabetes.

Read the detailed description

BetaFat is a 2-arm, unblinded study to compare gastric banding to treatment with metformin over a 24-month period in moderately obese adults with pre- or mild type 2 diabetes. The primary outcome will be change in β-cell compensation for insulin resistance, which the investigators will compare between groups. Secondary analyses will include other potential markers of β-cell health and potential mediators of treatment-specific effects. The main focus will be on mediators related to obesity. Clinically, the project will serve as a test of concept for use of gastric banding relatively early in the spectrum of obesity and β-cell disease. Biologically, the results will provide crucial information on potential mediators of β-cell failure and its arrest or reversal in the context of obesity. Those mediators will guide the development of more effective treatment and monitoring for the β-cell disease that causes type 2 diabetes.

Being tested
Metformin, gastric banding
Keywords
type 2 diabetes, prediabetes, obesity, gastric banding, metformin
Medical subject headings
Prediabetic State, Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

    metformin 1000 mg bid

  • gastric bandingDevice

    LAP-BAND

Study groups in NCT01763346
Study groupRoleWhat they receive
metforminActive comparatorsubjects receiving metformin
Receives: Drug: Metformin
gastric bandingExperimentalsubjects receiving LAP-BAND
Receives: Device: gastric banding

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Steady State Beta Cell Compensation

    mean plasma C-peptide concentration during clamp steady state, adjusted for mean clamp insulin sensitivity

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionJun 2018
  4. Study completionJun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01763346
Sponsor's protocol ID
BETAFAT
Other IDs
U01DK094430, IIT - 000395
Acronym
BetaFat
Status last verified
Sep 2019
First submitted
4 Jan 2013
Last updated
21 Oct 2019
Data monitoring committee
Yes

Publications

  • RISE Consortium. Restoring Insulin Secretion (RISE): design of studies of beta-cell preservation in prediabetes and early type 2 diabetes across the life span. Diabetes Care. 2014;37(3):780-8. doi: 10.2337/dc13-1879. Epub 2013 Nov 5.

    PubMed 24194506

  • Xiang AH, Trigo E, Martinez M, Katkhouda N, Beale E, Wang X, Wu J, Chow T, Montgomery C, Nayak KS, Hendee F, Buchanan TA; RISE Consortium; RISE Collaborators. Impact of Gastric Banding Versus Metformin on beta-Cell Function in Adults With Impaired Glucose Tolerance or Mild Type 2 Diabetes. Diabetes Care. 2018 Dec;41(12):2544-2551. doi: 10.2337/dc18-1662. Epub 2018 Oct 3.

    PubMed 30282699

  • RISE Consortium. Metabolic Contrasts Between Youth and Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes: I. Observations Using the Hyperglycemic Clamp. Diabetes Care. 2018 Aug;41(8):1696-1706. doi: 10.2337/dc18-0244. Epub 2018 Jun 25.

    PubMed 29941497

  • Tjaden AH, Edelstein SL, Arslanian S, Barengolts E, Caprio S, Cree-Green M, Lteif A, Mather KJ, Savoye M, Xiang AH, Kahn SE. Reproducibility of Glycemic Measures Among Dysglycemic Youth and Adults in the RISE Study. J Clin Endocrinol Metab. 2023 Sep 18;108(10):e1125-e1133. doi: 10.1210/clinem/dgad135.

    PubMed 36938582

  • Utzschneider KM, Ehrmann DA, Arslanian SA, Barengolts E, Buchanan TA, Caprio S, Edelstein SL, Hannon TS, Kahn SE, Kozedub A, Mather KJ, Nadeau KJ, Sam S, Tripputi M, Xiang AH, El Ghormli L; RISE Consortium. Weight loss and beta-cell responses following gastric banding or pharmacotherapy in adults with impaired glucose tolerance or type 2 diabetes: a randomized trial. Obesity (Silver Spring). 2022 Aug;30(8):1579-1588. doi: 10.1002/oby.23475.

    PubMed 35894078

  • Kahn SE, Edelstein SL, Arslanian SA, Barengolts E, Caprio S, Ehrmann DA, Hannon TS, Marcovina S, Mather KJ, Nadeau KJ, Utzschneider KM, Xiang AH, Buchanan TA; RISE Consortium; Rise Consortium Investigators:. Effect of Medical and Surgical Interventions on alpha-Cell Function in Dysglycemic Youth and Adults in the RISE Study. Diabetes Care. 2021 Sep;44(9):1948-1960. doi: 10.2337/dc21-0461. Epub 2021 Jun 16.

    PubMed 34135015

  • Kahn SE, Mather KJ, Arslanian SA, Barengolts E, Buchanan TA, Caprio S, Ehrmann DA, Hannon TS, Marcovina S, Nadeau KJ, Utzschneider KM, Xiang AH, Edelstein SL; RISE Consortium; Rise Consortium Investigators:. Hyperglucagonemia Does Not Explain the beta-Cell Hyperresponsiveness and Insulin Resistance in Dysglycemic Youth Compared With Adults: Lessons From the RISE Study. Diabetes Care. 2021 Sep;44(9):1961-1969. doi: 10.2337/dc21-0460. Epub 2021 Jun 15.

    PubMed 34131047

  • Arslanian SA, El Ghormli L, Kim JY, Tjaden AH, Barengolts E, Caprio S, Hannon TS, Mather KJ, Nadeau KJ, Utzschneider KM, Kahn SE; RISE Consortium. OGTT Glucose Response Curves, Insulin Sensitivity, and beta-Cell Function in RISE: Comparison Between Youth and Adults at Randomization and in Response to Interventions to Preserve beta-Cell Function. Diabetes Care. 2021 Mar;44(3):817-825. doi: 10.2337/dc20-2134. Epub 2021 Jan 12.

    PubMed 33436401

  • RISE Consortium. Obesity and insulin sensitivity effects on cardiovascular risk factors: Comparisons of obese dysglycemic youth and adults. Pediatr Diabetes. 2019 Nov;20(7):849-860. doi: 10.1111/pedi.12883. Epub 2019 Jul 29.

    PubMed 31301210

  • RISE Consortium. Metabolic Contrasts Between Youth and Adults With Impaired Glucose Tolerance or Recently Diagnosed Type 2 Diabetes: II. Observations Using the Oral Glucose Tolerance Test. Diabetes Care. 2018 Aug;41(8):1707-1716. doi: 10.2337/dc18-0243. Epub 2018 Jun 25.

    PubMed 29941498

  • Hannon TS, Kahn SE, Utzschneider KM, Buchanan TA, Nadeau KJ, Zeitler PS, Ehrmann DA, Arslanian SA, Caprio S, Edelstein SL, Savage PJ, Mather KJ; RISE Consortium. Review of methods for measuring beta-cell function: Design considerations from the Restoring Insulin Secretion (RISE) Consortium. Diabetes Obes Metab. 2018 Jan;20(1):14-24. doi: 10.1111/dom.13005. Epub 2017 Jun 22.

    PubMed 28493515

Questions about this trial

What is this clinical trial studying?

A study testing Metformin and gastric banding in people with Prediabetes and Type 2 Diabetes, run by University of Southern California at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Steady State Beta Cell Compensation (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01763346, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.

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Beta Cell Restoration Through Fat Mitigation | AzTrials