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Type 2 DiabetesNCT02520050

The Effect of 3 Different Models of MNT on DM Control in Overweight Patients With T2DM

A study testing Traditional MNT, Structured MNT and Structured MNT plus Weekly Support in people with Type 2 Diabetes and Obesity, run by Joslin Diabetes Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The American Diabetes Association (ADA), among other medical societies, is strongly recommending medical nutrition therapy (MNT) for prevention and management of type 2 diabetes. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Type 2 Diabetes, Obesity
What is being tested?
Traditional MNT, Structured MNT and Structured MNT plus Weekly Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteUnited States
Study dates
Apr 2015to Jul 2018
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 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.
  • Subject states that he/she had type 2 diabetes, as evidenced by use of anti-hyperglycemic medication or managed on lifestyle intervention only with A1C >7%
  • Subject is between 30 and 80 years of age.
  • Subject on stable dose of antihyperglycemic medications for the past 3 months or lifestyle intervention
  • Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. A urine pregnancy test is required for all female subjects unless she is not of childbearing potential, defined as postmenopausal for at least one year prior to screening visit or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
  • If a female is of childbearing potential, she is practicing one of the following methods of birth control (and continued through the duration of the study):
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  • Condoms, sponge, diaphragm or intrauterine device;
  • Oral or parenteral contraceptives for 3 months prior to screening visit;
  • Vasectomized partner;
  • Total abstinence from sexual intercourse.
  • Subject's BMI is > 25 kg/m2.
  • Subject has A1C between 7-10%
  • If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on stable dose for at least three months prior to screening visit. These medications will not be changed during intervention unless it is mandatory.

Who cannot join

  • Subjects using exogenous insulin since insulin titration may impact the primary endpoint.
  • Subject states that he/she had a history of diabetic ketoacidosis.
  • Subject is pregnant or lactating.
  • Subject uses corticosteroid treatment with the exception of inhaled or topical steroids in the last 3 months; or antibiotics within the last 3 weeks prior to the screening visit.
  • Subject states that he/she had an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).
  • Subject states that he/she has had a recent cardiovascular event (e.g., myocardial infarction, stroke) ≤ six months prior to screening visit; or stated history of congestive heart failure.
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  • Subject states that he/she has had end stage organ failure (such as end stage renal disease) or had status post organ transplant.
  • Subject states that he/she has had a history of renal disease (Creatinine >1.5mg/dL or GFR <60 mL/min/1.73 m2).
  • Subject states that he/she has had current hepatic disease.
  • Subject has history of gastroparesis.
  • Subject states that he/she has had a chronic, contagious, infectious disease
  • Subject states that he/she has had clotting or bleeding disorders.
  • Subject is known to be allergic or intolerant to any ingredient found in the study products.
  • Subject is known to have a history of special nutritional need requiring special diet.
  • Subject is currently participating in any weight loss program.
  • Subject has used meal replacements during the 3 months prior to the start of the study.
  • Subject has history of bariatric surgery.
  • -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: The Effect of Three Different Models of Medical Nutrition Therapy (MNT) on Diabetes Control in Overweight and Obese Patients With Type 2 Diabetes: A Randomized Comparative Study. (Nutrition Path Study)

The American Diabetes Association (ADA), among other medical societies, is strongly recommending medical nutrition therapy (MNT) for prevention and management of type 2 diabetes. However, the ADA recognized that there is no "one size fits all" diet and thus recommends that MNT should be conducted through a consultation with registered dietitians (RD). Previous studies have shown that using diabetes-specific nutritional formulas, as an integral part of the MNT, lowers postprandial blood glucose levels. Through our experience from the Joslin's Weight Achievement and Intensive Treatment (Why WAIT™) program, applying MNT within a structured dietary intervention protocol has the best impact on blood glucose values and body weight. Meanwhile, the frequent use of health coaching during dietary intervention proved to be effective in managing diabetes and inducing weight loss. However, no study compared those three intervention methods in a randomized clinical study.

The aim of this study is to evaluate the effect of different models of conducting medical nutrition therapy on the glycemic control in patients with type 2 diabetes.

Being tested
Traditional MNT, Structured MNT, Structured MNT plus Weekly Support
Keywords
Type 2 diabetes, Obesity, Nutrition, Medical Nutrition Therapy
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.

  • Traditional MNTBehavioural

    Will follow the nutritional recommendations set by the American Diabetes Association in 2013.

  • Structured MNTBehavioural

    Also called Medical Nutritional Therapy Plan

    Will follow a meal plan developed at Joslin plus use of use of diabetes-specific nutritional formula.

  • Structured MNT plus Weekly SupportBehavioural

    Will follow a meal plan developed at Joslin plus use of use of diabetes-specific nutritional formula; in addition to receiving weekly coaching from a registered dietitian

Study groups in NCT02520050
Study groupRoleWhat they receive
Traditional MNTActive comparatorWill be instructed to follow a MNT plan as recommended by the ADA through consultation with a RD.
Receives: Behavioral: Traditional MNT
Structured MNTActive comparatorWill be instructed to follow a MNT plan as applied in the Why WAIT™ program, which includes structured dietary plan, dietary modification and use of diabetes-specific meal replacement (Ultra Glucose Control®; Metagenics Inc.) three times per day.
Receives: Behavioral: Structured MNT
Structured MNT plus Weekly SupportActive comparatorWill be instructed to follow a MNT plan as applied in the Why WAIT™ program, which includes structured dietary plan, dietary modification and use of diabetes-specific meal-replacement (Ultra Glucose Control®; Metagenics Inc.) three times per day plus weekly coaching.
Receives: Behavioral: Structured MNT plus Weekly Support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute and relative change in HbA1c

    Measured: 16 weeks

Secondary outcomes (14)

  1. Absolute and relative change in body weight

    Measured: 16 weeks

  2. Absolute and relative change in fasting blood glucose

    Measured: 16 weeks

  3. Absolute and relative change in lipid profile (cholesterol, HDL, LDL, triglycerides)

    Measured: 16 weeks

  4. Absolute and relative change in blood pressure

    Measured: 16 weeks

  5. Absolute and relative change in High-sensitivity C - reactive protein (hsCRP)

    Measured: 16 weeks

  6. Absolute and relative change in HOMA insulin resistance (IR) index

    Measured: 16 weeks

  7. Absolute and relative change in c-peptide level

    Measured: 16 weeks

  8. Absolute and relative change in microalbumin/creatinine ratio

    Measured: 16 weeks

  9. Absolute and relative change in fat mass

    Measured: 16 weeks

  10. Absolute and relative change in body fat percentage

    Measured: 16 weeks

  11. Absolute and relative change in waist/hip ratio

    Measured: 16 weeks

  12. Absolute and relative change in visceral fat content

    Measured: 16 weeks

  13. Absolute and relative change in dietary protein

    Measured: 16 weeks

  14. Absolute and relative change in energy intake

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionJul 2018
  4. Study completionJul 2018

Resources

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
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02520050
Sponsor's protocol ID
CHS#: 2014-40
Status last verified
May 2026
First submitted
4 Aug 2015
Last updated
29 May 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Mottalib A, Salsberg V, Mohd-Yusof BN, Mohamed W, Carolan P, Pober DM, Mitri J, Hamdy O. Effects of nutrition therapy on HbA1c and cardiovascular disease risk factors in overweight and obese patients with type 2 diabetes. Nutr J. 2018 Apr 7;17(1):42. doi: 10.1186/s12937-018-0351-0.

    PubMed 29626933

Questions about this trial

What is this clinical trial studying?

A study testing Traditional MNT, Structured MNT and Structured MNT plus Weekly Support in people with Type 2 Diabetes and Obesity, run by Joslin Diabetes Center 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 13 inclusion and 18 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 29 May 2026. 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?

Absolute and relative change in HbA1c (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02520050, which also lists 1 linked publication.

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 29 May 2026.

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