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Almased Multi-Center Diabetes Intervention Trial | Clinical Trials | Clareo Health

COMPLETEDNA

Almased Multi-Center Diabetes Intervention Trial

Evaluation of Almased on Glycemic Control and Metabolic Effects in Patients With Type 2 Diabetes

NCT01702012•Wake Forest University Health Sciences

Summary

A 12 month multi-center randomization controlled study. Participants will be randomized to either a lifestyle education program or a meal replacement regimen with Almased, after an initial examination of eligibility criteria. Primary outcome-HbA1c

Detailed Description

Age 21 + Male/Female gender Type 2 Diabetes Non-insulin dependent BMI 25-40 kg/m HbA1c 7.5-10%

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Type 2 diabetes mellitus: Diabetes mellitus will be determined by medical records, current treatment, verification from personal health care provider, or test results meeting the 2010 American Diabetes Association criteria of fasting glucose ≥126 mg/dl, symptoms of hyperglycemia with casual plasma glucose \> 200 mg/dl or two-hour plasma glucose ≥200 mg/dl after a 75 gram oral glucose load. Individuals who have a clinical history strongly suggestive of type 1 diabetes will be excluded. Individuals taking oral hypoglycemic medication with diet and exercise are eligible. Subjects taking insulin will not be eligible for entry into the study.
•Body mass index: Overweight and obese individuals, with body mass index 25 - 40 kg/m2, are eligible. Weight loss is recommended for overweight diabetic participants with one or more cardiovascular risk factors.
•Age: Individuals older than 21 years are eligible.
•Ethnicity: All ethnic groups are eligible for the study.
•Blood pressure: AMDIT will enroll individuals whose blood pressure is under at least moderate control. For safety purposes, moderate control will be defined in this study as systolic values under 160 mm/Hg and diastolic values under 100 mm/Hg. Individuals whose blood pressure exceeds these levels during screening will be advised to seek treatment and may be re-evaluated following initiation of antihypertensive treatment.
•Glycemic control: AMDIT will enroll individuals whose HbA1c is between 7.5 and 10%. Individuals whose HbA1c exceeds this level may require more urgent care and will be told to seek treatment and may also be re-evaluated for inclusion.
•Lipid control: Individuals with a fasting triglycerides concentration less than 500 mg/dl are eligible.
•Willingness to participate: Participants must be willing to be randomized to either Almased or the Lifestyle Intervention and to follow the protocol to which they have been assigned. Individuals must be willing to modify their diet and their activity if they are assigned to the Lifestyle Intervention.

Exclusion Criteria

•Psychotic disorders or bipolar disorders, hospitalization for depression in past six months;
•Self-report of alcohol or substance abuse within the past twelve months, current consumption of more than 14 alcoholic drinks per week, and/or current acute treatment or rehabilitation program for these problems;
•Plans to relocate to an area not served by AMDIT or travel plans that do not permit full participation in the study;
•Known allergies to soy or dairy;
•Current use of medications for weight loss;
•Self-reported inability to walk two blocks;
•History of bariatric surgery, small bowel resection, or extensive bowel resection;
•Chronic treatment with systemic corticosteroids as weight gain associated with steroids may interfere with the intervention goals;
•Candidates who have definite plans to move out of the area within the study period;
•Candidates with any dietary practice, behavior, or attitude that would substantially limit adherence to the intervention;
+14 more criteria

Locations (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Key Dates

Start Date

January 1, 2013

Primary Completion Date

April 1, 2015

Completion Date

May 1, 2015

Last Updated

January 31, 2020

Enrollment

240

ACTUAL participants

Conditions

Type 2 DiabetesObesity

Interventions

Almased Meal Replacement Powder

DIETARY_SUPPLEMENT

Group-Based Lifestyle Intervention

BEHAVIORAL

Feasibility of a Tailored Online Self-compassion Intervention

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Almased Multi-Center Diabetes Intervention Trial

Inclusion Criteria

Exclusion Criteria

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