NCT01763346

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

October 21, 2019

Completed
Last Updated

October 21, 2019

Status Verified

September 1, 2019

Enrollment Period

5 years

First QC Date

January 4, 2013

Results QC Date

August 28, 2019

Last Update Submit

October 15, 2019

Conditions

PrediabetesType 2 DiabetesObesity

Keywords

type 2 diabetesprediabetesobesitygastric bandingmetformin

Outcome Measures

Primary Outcomes (1)

  • Steady State Beta Cell Compensation

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

    24 months

Other Outcomes (2)

  • Glycemia

    24 months

  • Glycemia

    24 months

Study Arms (2)

metformin

ACTIVE COMPARATOR

subjects receiving metformin

Drug: Metformin

gastric banding

EXPERIMENTAL

subjects receiving LAP-BAND

Device: gastric banding

Interventions

MetforminDRUG

metformin 1000 mg bid

metformin
gastric bandingDEVICE

LAP-BAND

gastric banding

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 91011, United States

Location

Related Publications (11)

  • 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.

    PMID: 24194506BACKGROUND

  • 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.

    PMID: 30282699RESULT

  • 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.

    PMID: 29941497RESULT

  • 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.

    PMID: 36938582DERIVED

  • 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.

    PMID: 35894078DERIVED

  • 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.

    PMID: 34135015DERIVED

  • 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.

    PMID: 34131047DERIVED

  • 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.

    PMID: 33436401DERIVED

  • 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.

    PMID: 31301210DERIVED

  • 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.

    PMID: 29941498DERIVED

  • 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.

    PMID: 28493515DERIVED

MeSH Terms

Conditions

Prediabetic StateDiabetes Mellitus, Type 2Obesity

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
Dr. Thomas Buchanan
Organization
University or Southern California
buchanan@usc.edu
3234794319

Study Officials

  • Thomas A Buchanan, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 4, 2013

First Posted

January 8, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

October 21, 2019

Results First Posted

October 21, 2019

Record last verified: 2019-09

Locations

US(1)