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NCT Number: NCT01729117

A Trial of Meal Replacement at a Community Diabetes Clinic Serving a Low Socioeconomic Hispanic Population

Background and Rationale Research studies have shown that patients with type 2 diabetes (T2DM) who lose weight have better glucose control and less risk for heart disease. It has been difficult to achieve these results in a non-research setting. Meal replacements (MR) are pre-packaged meals with appropriate calories and nutrients that enhance adherence to a weight loss program by reducing decision-making and facilitating target caloric intake. The University of Southern California (USC) arm of the NIH funded Look AHEAD study at Roybal Clinic has demonstrated acceptability and success of MRs in conjunction with a structured lifestyle modification program in achieving weight loss in underserved Hispanic T2DM patients.

Objectives Our short-term objective is to determine the efficacy, safety and feasibility of a 3-month full MR program in conjunction with a 1 year standardized lifestyle modification program in a clinic setting. Our longer-term goal is to acquire data for sample size and power estimates for a larger NIH- or other funded prospective, randomized trial.

Study Methodology A 1-year, prospective trial study of 30 obese subjects with T2DM treated with insulin randomized to 2 groups: standard care (SC) or Meal Replacement group (MR). The SC will receive usual care at Roybal Diabetes Management Clinic (DMC). The MR will receive MRs and a lifestyle course in addition to the usual clinical care at the Roybal DMC. Phase 1 consists of 3-months 1200 -1400cal diet using full MR. Phase 2 consists of a 3-month transition to the same caloric intake using regular meals and 1 MR/day . Phase 3 consists of a 6-month weight loss maintenance period with 1 MR/day. This will be about 1400-1600 calories/day for women and 1800 to 2000 calories/day for men. Individual and group educational, support and counseling visits will be components of all 3 phases of the study.

Outcomes Efficacy of the program will be determined by weight, waist measurement and waist to hip ratio, blood pressure, HbA1c, lipids, and medication use at baseline and at 3, 6, 9 and 12 months. These are all measurements that are done routinely in these patients. Safety will be determined by monitoring of adverse events.

Data Analysis We will compare the outcomes between the SC and MR at 0,3,6,9 and 12 months to determine if there is evidence that the intervention improves outcomes and is safe.

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Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roybal Diabetes Management Clinic

Los Angeles, California, 90022, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Demographic

  • Age >18 years
  • Enrolled in the Roybal Diabetes Management Clinic
  • Self-described as Hispanic
  • Willing and able to participate in Spanish language group sessions.
  • Willing and able to attend study visits for the duration of the study at the allocated times.
  • Willing and able to maintain a food exercise and medication log and perform and record self-monitoring of blood glucose (SMBG) Clinical
  • T2DM diagnosed by fasting blood glucose >126mg/dL or random blood glucose >200mg/dL
  • BMI>30 kg/m2
  • If a woman of childbearing potential, using effective contraception. Biochemical HbA1c 8%-12% Medication
  • On insulin therapy

Exclusion criteria

Medical conditions

  • Type 1 DM
  • Illness likely to lead to unstable weight or altered glucose control.
  • Proliferative diabetic retinopathy on eye examination within the last 6 months.
  • Gallstones suspected on clinical history or documented on ultrasound.
  • Serum creatinine >1.5mg/dL
  • Symptomatic cardiovascular disease
  • Documented liver disease other than fatty liver
  • Lactating, pregnant or intending to become pregnant within the following year Psycho-social conditions
  • Inability or unwillingness to participate in a Spanish-language lifestyle group.
  • Eating disorder such as bulimia
  • Uncontrolled psychiatric disorder such as severe uncontrolled depression or bipolar disorder.
  • Inability to attend scheduled appointments regularly for the duration of the study Medication use
  • Use of weight loss medication within previous 3 months including exenatide.
  • Use of medication (other than diabetes medication) likely to lead to unstable weight or altered glucose control
  • Laxative or substance abuse
  • More than 10 alcoholic drinks/week

Treatment and study plan

Meal replacement

Other

5 Meal Replacements/day will be given for 3 months and then 1/day for 9 months.

Other names: HMR70 Plus products; HMR Boston, Massachusetts

Standard care

Other

Standard Care only

Primary outcomes

  1. Change in BMI

    Time frame: 12months

Secondary outcomes

  1. Severe Hypoglycemic Events

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

The 1,2,3 Plan: A Randomized Controlled Trial of Meal Replacement With a Lifestyle Modification Program vs. Standard Care at a Community Diabetes Clinic Serving a Low Socioeconomic Hispanic Population

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 20, 2012
Registry last updated
Nov 20, 2012

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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