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NCT Number: NCT03225209

Medically Reproducing Bariatric Surgery

Type 2 diabetes (DM2) is a chronic disease affecting 29 million Americans and a leading cause of blindness, kidney failure, and limb loss (Engelgau et al 2004). Roux-en-Y gastric bypass (RYGB) is the only intervention that leads to durable DM2 remission ~ 80% of the time (Mingrone et al 2012). Yet, it's broad application is limited by cost, invasiveness, and clinical inertia. Medically reproducing RYGB would extend the benefit of disease remission to the vast majority of DM2 patients using a cheaper, less invasive and more palatable treatment approach. Although all of the mechanisms mediating DM2 remission are not known, it is widely accepted that RYGB induces caloric restriction and enhances meal-stimulated release of a gut-peptide called glucagon-like-peptide-1 (GLP-1) both of which improve glycemic control in type 2 diabetes (Dar et al 2012; Jackness 2013). Caloric restriction can be achieved using OPTIFAST which is a commercially available medical weight loss program that has demonstrated the ability to decrease weight and improve glycemic control (Kirschner et al; 1998). Enhanced meal-stimulated GLP-1 release can be achieved using Liraglutide an FDA-approved once daily GLP-1 analogue that improves glycemic control and induces weight loss.

The investigators hypothesize that adding OPTIFAST (caloric restriction) in suboptimally controlled DM2 patients on Liraglutide (enhanced meal stimulated GLP-1 release), Metformin and Lantus insulin will medically reproduce RYGB and lead to DM2 remission, weight loss, decreased medication intensity and improved health related quality of life.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Veteran Affairs, Greenville Health Care Center

Greenville, North Carolina, 27834, United States

About this study

This is a 24 week "proof of concept" study that will examine if adding "caloric restriction" (OPTIFAST) to "enhanced GLP-1 release" (Liraglutide) will lead to discontinuation of Lantus and Metformin. The primary outcome measure is change in glycemic control measured as hemoglobin A1C. Secondary outcome measures are change in weight, medication intensity and health related quality of life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male or female
  • age 25-70 years
  • BMI > 30
  • diagnosis of type 2 diabetes
  • weight stable for 3 months
  • hemoglobin A1C >7% and <10%
  • on Liraglutide
  • on Metformin
  • on Lantus
  • interested in losing weight
  • agreeable to regular visits per study protocol
  • access to telephone and reliable transportation
  • has a VAMC provider

Exclusion criteria

  • age >70
  • A1C <7% or >10%
  • current use of prandial insulin
  • current use of sulfonylurea or any other oral agent except for Metformin
  • current sue of any other basal insulin except for Lantus
  • pregnant
  • breast feeding
  • prior history of pancreatitis
  • prior history of gastroparesis
  • history of thyroid cancer/multiple endocrine neoplasia/thyroid nodules/medullary thyroid cancer
  • history of gallstones
  • history of hyperoxaluria or calcium oxalate nephrolithiasis
  • AST/ALT > 2 times the upper limit of normal
  • current or past history of liver disease
  • history of Roux-en-Y gastric bypass or gastric sleeve or any other bariatric procedure
  • type 1 diabetes
  • any gastrointestinal disease causing malabsorption
  • unwilling or unable to complete scheduled testing
  • thiazolidinedione use within past 6 months
  • any serious and/or unstable medical, psychiatric, or other condition(s) that prevents the patient from providing informed consent or complying with the study
  • organ transplantation or those on immunosuppressants
  • chronic anticoagulation
  • recent myocardial infarction, unstable angina, stroke, coronary artery bypass or transient ischemia attacks in the past 6 months
  • chronic prednisone use
  • peptic ulcer disease in past 6 months
  • acute gastrointestinal disorders
  • hepatitis
  • cirrhosis
  • GFR < 50
  • deep vein thrombosis in the past 6 months
  • bone fractures in the past 6 months
  • lithium use
  • active malignancy
  • substance abuse
  • unstable psychiatric condition
  • history of suicidal ideation
  • enrolled in another research study related to diet and/or physical activity

Treatment and study plan

OPTIFAST

Other

OPTIFAST meal replacement includes shakes, bars and soups. These meal replacements will completely replace the subject's diet for the first 12 weeks of the study (baseline-week 12) followed by a gradual transition back to prepared meals over 6 weeks (week 13-18). Attempt will be made to reduce or eliminate Lantus and Metformin as long as glycemic control is maintained.

Primary outcomes

  1. Change in Glycemic control

    Time frame: Change in HbA1c from baseline at week 12 and week 24 will be measured

    Hemoglobin A1C (HbA1C) will be used to assess glycemic control during the study

Secondary outcomes

  1. Change in Weight

    Time frame: Change in weight in kilograms from baseline at week 12 and week 24 will be measured

    Weight in kilograms will be used to assess weight change during the study

  2. Change in Medication intensity

    Time frame: Change in MES from baseline at week 12 and week 24 will be measured

    Medication effect score (MES) will be used to assess medication intensity during the study

  3. Change in Health Related Quality of Life (HRQOL)

    Time frame: Change in PAID from baseline at week 12, and week 24 will be measured

    Problem Areas in Diabetes Scale (PAID) is a well-validated measure used in clinical trials regarding diabetes and is a sensitive and specific measure of HRQOL.

  4. Change in Health Related Quality of Life

    Time frame: Change in EQ-5D-5L from baseline at week 12 and week 24 will be measured

    EQ-5D-5L is a highly sensitive 5-item health status measure with good performance in Veteran outpatients. It assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

  5. Change in Physical activity

    Time frame: Change in IPAQ from baseline at week 12 and week 24 will be measured

    International Physical Activity Questionnaire (IPAQ) is a well validated tool to assess daily physical activity

Sponsors and collaborators

Lead sponsor

Moahad S Dar

Other

Collaborators

  • Durham VA Medical Center
  • East Carolina University
  • Société des Produits Nestlé (SPN)

Registry information

Acronym: MRB

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 21, 2017
Registry last updated
Jan 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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