Diabetes Mellitus, Type 2NCT02896140
Effect of Dairy Consumption on Glycemic Control, Body Weight and Cardiovascular Risk Factors
An observational study of Diabetes Mellitus, Type 2 and Obesity, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
The aim of this study is to determine the relationship between the percentage of calories from dairy intake and long-term glycemic control and weight maintenance in patients with type 2 diabetes who participate in an intensive lifestyle intervention program. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- Type 2 diabetes in WhyWAIT Program
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Sep 2018
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants in Joslin Diabetes Center's Weight Achievement and Intensive Treatment (Why WAIT) program
Who may be able to join
- Subject is participating in the Weight Achievement and Intensive Treatment (Why WAIT) program
- Subject is male or female ages 18-75
- Subject has type 2 diabetes for at least three months prior to screening and treated with any antihyperglycemic medication
Who cannot join
- Subject is pregnant or lactating
- Subject has a heart pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dairy Product Consumption on Glycemic Control, Body Weight and Cardiovascular Risk Factors in Patients Enrolled in the Joslin Weight Achievement and Intensive Treatment (Why WAIT) Program: A Prospective Cohort Study
The aim of this study is to determine the relationship between the percentage of calories from dairy intake and long-term glycemic control and weight maintenance in patients with type 2 diabetes who participate in an intensive lifestyle intervention program.
The investigators hypothesize that overweight and obese patients with type 2 diabetes who consume higher percentage of calories from dairy products during intensive lifestyle intervention programs have better glycemic control and maintenance of weight loss as compared to those who consume lower percentage of calories from dairy products.
Read the detailed description
This is a prospective, observational clinical study where the daily intake of dairy products will be recorded and analyzed in 50 overweight/obese subjects with type 2 diabetes enrolled in the Weight Achievement and Intensive Treatment (Why WAIT) program. The Weight Achievement and Intensive Treatment (Why WAIT) program is a 12-week multidisciplinary program developed by Joslin Diabetes Center for intensive diabetes weight management in clinical practice. It includes the following components that are provided in a group setting: (1) intensive medical treatment provided by an endocrinologist and a registered nurse; (2) a structured dietary plan provided by a registered dietitian; (3) an individualized exercise training program provided by an exercise physiologist; (4) cognitive behavioral modification provided by a behavioral therapist.
Participants will be enrolled in this study for a period of 24 weeks. They will attend the Weight Achievement and Intensive Treatment (Why WAIT) program during the first 12 weeks of the study and will be followed for another 12 weeks after the program (the maintenance phase). During the intervention phase, participants will receive group education on a weekly basis for 12 consecutive weeks. During maintenance phase, participants will receive a monthly, 15 minute long, follow up phone call from the study dietitian.
Participants will be instructed to complete a 3-day food log before each visit. They will also be asked to record their dairy intake on a daily basis in a dedicated log book. These logs will be collected and analyzed by the study dietitian. Dairy consumption will be calculated as the sum of servings per day of milk, cheese, yogurt, and other dairy foods.
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Being tested
- Type 2 diabetes in WhyWAIT Program
- Keywords
- Type 2 diabetes, Obesity, Nutrition, Dairy
- 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.
Type 2 diabetes in WhyWAIT ProgramOther
The sum of servings per day of milk, cheese, yogurt, and other dairy foods.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes in WhyWAIT Program | Patients with type 2 diabetes who are participating in Joslin Diabetes Center's 12-week intensive diabetes weight management program (WhyWAIT). Receives: Other: Type 2 diabetes in WhyWAIT Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1C (A1C)
Measured: 24 weeks
Secondary outcomes (16)
Change in body weight
Measured: 24 weeks
Change in low-density lipoprotein (LDL)
Measured: 24 weeks
Change in high-density lipoprotein (HDL)
Measured: 24 weeks
Change in total cholesterol
Measured: 24 weeks
Change in triglycerides
Measured: 24 weeks
Change in fasting plasma glucose
Measured: 24 weeks
Change in Homeostatic model assessment (HOMA) insulin resistance (IR) index
Measured: 24 weeks
Height in meters
Measured: 24 weeks
Change in body fat percentage
Measured: 24 weeks
Change in fat free mass
Measured: 24 weeks
Change in total body water
Measured: 24 weeks
Change in waist circumference
Measured: 24 weeks
Change in trunk fat percentage
Measured: 24 weeks
Change in visceral fat level
Measured: 24 weeks
Change in blood pressure
Measured: 24 weeks
Change in c-reactive protein level
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Osama Hamdy, MD, PhD, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896140
- Sponsor's protocol ID
- 2016-07
- Status last verified
- Aug 2026
- First submitted
- 26 Apr 2016
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dairy Product Consumption on Glycemic Control, Body Weight and Cardiovascular Risk Factors in Patients Enrolled in the Joslin Weight Achievement and Intensive Treatment (Why WAIT) Program: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02896140
- Acronym / sponsor ID
- 2016-07
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Keywords
- Type 2 diabetes, Obesity, Nutrition, Dairy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 12 Sep 2016 (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.
The aim of this study is to determine the relationship between the percentage of calories from dairy intake and long-term glycemic control and weight maintenance in patients with type 2 diabetes who participate in an intensive lifestyle intervention program.
The investigators hypothesize that overweight and obese patients with type 2 diabetes who consume higher percentage of calories from dairy products during intensive lifestyle intervention programs have better glycemic control and maintenance of weight loss as compared to those who consume lower percentage of calories from dairy products.
Detailed description
This is a prospective, observational clinical study where the daily intake of dairy products will be recorded and analyzed in 50 overweight/obese subjects with type 2 diabetes enrolled in the Weight Achievement and Intensive Treatment (Why WAIT) program. The Weight Achievement and Intensive Treatment (Why WAIT) program is a 12-week multidisciplinary program developed by Joslin Diabetes Center for intensive diabetes weight management in clinical practice. It includes the following components that are provided in a group setting: (1) intensive medical treatment provided by an endocrinologist and a registered nurse; (2) a structured dietary plan provided by a registered dietitian; (3) an individualized exercise training program provided by an exercise physiologist; (4) cognitive behavioral modification provided by a behavioral therapist.
Participants will be enrolled in this study for a period of 24 weeks. They will attend the Weight Achievement and Intensive Treatment (Why WAIT) program during the first 12 weeks of the study and will be followed for another 12 weeks after the program (the maintenance phase). During the intervention phase, participants will receive group education on a weekly basis for 12 consecutive weeks. During maintenance phase, participants will receive a monthly, 15 minute long, follow up phone call from the study dietitian.
Participants will be instructed to complete a 3-day food log before each visit. They will also be asked to record their dairy intake on a daily basis in a dedicated log book. These logs will be collected and analyzed by the study dietitian. Dairy consumption will be calculated as the sum of servings per day of milk, cheese, yogurt, and other dairy foods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes in WhyWAIT Program | – | Other: Type 2 diabetes in WhyWAIT ProgramPatients with type 2 diabetes who are participating in Joslin Diabetes Center's 12-week intensive diabetes weight management program (WhyWAIT). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in Joslin Diabetes Center's Weight Achievement and Intensive Treatment (Why WAIT) program
Key inclusion criteria (3 listed)
- Subject is participating in the Weight Achievement and Intensive Treatment (Why WAIT) program
- Subject is male or female ages 18-75
- Subject has type 2 diabetes for at least three months prior to screening and treated with any antihyperglycemic medication
Key exclusion criteria (2 listed)
- Subject is pregnant or lactating
- Subject has a heart pacemaker
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 |
|---|---|---|
| Type 2 diabetes in WhyWAIT ProgramThe sum of servings per day of milk, cheese, yogurt, and other dairy foods. | Other | Type 2 diabetes in WhyWAIT Program |
Primary outcome
Change in Hemoglobin A1C (A1C)
Time frame: 24 weeks
16 secondary outcomes
Change in body weight
Time frame: 24 weeks
Change in low-density lipoprotein (LDL)
Time frame: 24 weeks
Change in high-density lipoprotein (HDL)
Time frame: 24 weeks
Change in total cholesterol
Time frame: 24 weeks
Change in triglycerides
Time frame: 24 weeks
Change in fasting plasma glucose
Time frame: 24 weeks
Change in Homeostatic model assessment (HOMA) insulin resistance (IR) index
Time frame: 24 weeks
Height in meters
Time frame: 24 weeks
Change in body fat percentage
Time frame: 24 weeks
Change in fat free mass
Time frame: 24 weeks
Change in total body water
Time frame: 24 weeks
Change in waist circumference
Time frame: 24 weeks
Change in trunk fat percentage
Time frame: 24 weeks
Change in visceral fat level
Time frame: 24 weeks
Change in blood pressure
Time frame: 24 weeks
Change in c-reactive protein level
Time frame: 24 weeks
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 10 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Osama Hamdy, MD, PhD principal investigator
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 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 3 inclusion and 2 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 10 Aug 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?
Change in Hemoglobin A1C (A1C) (time frame: 24 weeks). 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 10 Aug 2026.