Type 2 DiabetesAMDITNCT01702012
Almased Multi-Center Diabetes Intervention Trial
A study testing Almased Meal Replacement Powder and Group-Based Lifestyle Intervention in people with Type 2 Diabetes and Obesity, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Obesity
- What is being tested?
- Almased Meal Replacement Powder and Group-Based Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 33Show fewer
- 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:• Unable or unwilling to give informed consent or communicate with local study staff;
- 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;
- Currently pregnant or nursing;
- Cancer requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g. Stage 1 cervical cancer);
- HIV positive (self-report), due to effects on weight and body composition of HIV and medications used to treat HIV;
- Active tuberculosis (self-report);
- Cardiovascular or cardiopulmonary disease including a heart attack or procedure within the past three months; participation in a cardiac rehabilitation program within last three months; stroke or history/treatment for transient ischemic attacks in the past three months; documented history of pulmonary embolus in past six months; unstable angina pectoris or angina pectoris at rest; known history of cardiac arrest; known history of complex ventricular arrhythmia at rest or with exercise; known history of uncontrolled atrial fibrillation (heart rate of 100 beats per minute or more); known history of NYHA Class III or IV congestive heart failure; known history of acute myocarditis, pericarditis or hypertrophic myocardiopathy; known history of clinically significant aortic stenosis; known history of left bundle branch block or cardiac pacemaker unless evaluated by a cardiologist; cardiac defibrillator; heart transplant; known history of aortic aneurysm of at least 7 cm in diameter or aortic aneurysm repair;
- Renal disease: urine dipstick protein of 4+ (equivalent to approximately > 1 g/day), serum creatinine exceeding 1.4 mg/dl (women) or 1.5 mg/dl (men), or currently receiving dialysis;
- Known history of chronic obstructive pulmonary disease that would limit ability to follow the protocol;
- Self-reported chronic hepatitis B or C or cirrhosis;
- Inflammatory bowel disease requiring treatment in the past year;
- Known history of Cushing's syndrome (clinic diagnosis or self-report);
- Known history of Acromegaly (clinical diagnosis or self-report);
- Amputation of lower limbs as result of non-traumatic causes;
- Any major organ transplant (does not include cornea or hair transplants);
- Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the clinical site.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Evaluation of Almased on Glycemic Control and Metabolic Effects in Patients With Type 2 Diabetes
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
Read the detailed description
Age 21 + Male/Female gender Type 2 Diabetes Non-insulin dependent BMI 25-40 kg/m HbA1c 7.5-10%
- Conditions
- Type 2 Diabetes, Obesity
- Being tested
- Almased Meal Replacement Powder, Group-Based Lifestyle Intervention
- Keywords
- Diabetes-Obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Almased Meal Replacement PowderDietary supplement
Commercially available meal replacement product that contains soy protein, honey, yogurt, and amino acids. Participants assigned to this arm will receive the Almased meal replacement product and will be asked to replace one meal per day during the first 6 month. During the second 6 months, they will be allowed to choose to continue using the Almased as a meal replacement or to use it as a supplement prior to meals.
Group-Based Lifestyle InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Almased Meal Replacement Powder | Experimental | Participants assigned to this arm will receive the Almased meal replacement powder and will be asked to replace one meal per day during the first 6 months of participation. During the second 6 months, participants will be allowed to choose whether to continue using the product to replace a meal or to use the product as a supplement prior to meals. Receives: Dietary Supplement: Almased Meal Replacement Powder |
| Lifestyle Intervention | Active comparator | Participants randomized to this group will receive 5 group sessions in the first two months of participation and 5 additional group sessions in the last two months. These group sessions will focus on lifestyle behavior changes for weight loss and management including goal-setting, calorie balance, general nutrition, and physical activity. Receives: Behavioral: Group-Based Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c (%)
Measured: 2, 4, 6, 8, 10, and 12 months
Secondary outcomes (2)
Change in HOMA IR Index
measure changes in Homeostasis Model of Insulin Resistance
Measured: 2, 4, 6, 8, 10, and 12 months
Change in fasting blood glucose (mg/dl)
Measured: 2, 4, 6, 8, 10, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startJan 2013
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Freiburg, University of Campinas, Brazil, London Metropolitan University, University of Mysore
- Responsible party
- Sponsor
- Investigators
- Mara Z Vitolins, DrPH MPH RD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702012
- Sponsor's protocol ID
- IRB00020672
- Acronym
- AMDIT
- Status last verified
- Jan 2020
- First submitted
- 3 Oct 2012
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Almased on Glycemic Control and Metabolic Effects in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01702012
- Acronym / sponsor ID
- AMDIT / IRB00020672
- Conditions
- Type 2 Diabetes, Obesity
- Keywords
- Diabetes-Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- University of Freiburg, University of Campinas, Brazil, London Metropolitan University, University of Mysore
- Study start
- Jan 2013 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 5 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Almased Meal Replacement Powder | Experimental | Dietary Supplement: Almased Meal Replacement PowderParticipants assigned to this arm will receive the Almased meal replacement powder and will be asked to replace one meal per day during the first 6 months of participation. During the second 6 months, participants will be allowed to choose whether to continue using the product to replace a meal or to use the product as a supplement prior to meals. |
| Lifestyle Intervention | Active comparator | Behavioral: Group-Based Lifestyle InterventionParticipants randomized to this group will receive 5 group sessions in the first two months of participation and 5 additional group sessions in the last two months. These group sessions will focus on lifestyle behavior changes for weight loss and management including goal-setting, calorie balance, general nutrition, and physical activity. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Almased Meal Replacement PowderCommercially available meal replacement product that contains soy protein, honey, yogurt, and amino acids. Participants assigned to this arm will receive the Almased meal replacement product and will be asked to replace one meal per day during the first 6 month. During the second 6 months, they will be allowed to choose to continue using the Almased as a meal replacement or to use it as a supplement prior to meals. | Dietary supplement | Almased Meal Replacement Powder |
| Group-Based Lifestyle Intervention | Behavioural | Lifestyle Intervention |
Primary outcome
Change in HbA1c (%)
Time frame: 2, 4, 6, 8, 10, and 12 months
2 secondary outcomes
Change in HOMA IR Index
Time frame: 2, 4, 6, 8, 10, and 12 months
Change in fasting blood glucose (mg/dl)
Time frame: 2, 4, 6, 8, 10, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mara Z Vitolins, DrPH MPH RD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Almased Meal Replacement Powder and Group-Based Lifestyle Intervention in people with Type 2 Diabetes and Obesity, run by Wake Forest University Health Sciences 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 33 inclusion and 0 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 31 Jan 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in HbA1c (%) (time frame: 2, 4, 6, 8, 10, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2020.