Type 2 DiabetesNCT03726762
Effects of Replacing Diet Beverages With Water on Weight Maintenance of Type 2 Diabetic Obese Women: 18 Months Follow up
A study of Type 2 Diabetes and Overweight, run by Novindiet Clinic at 1 site in Iran.
Trial summary
the present study aimed to follow up our participants in order to consider the changes in weight and anthropometric measurements after the 12-month weight maintenance as well as the total of 18 months, consisting of the previously described 24 weeks active weight loss and a further 53 weeks weight maintenance. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Type 2 Diabetes, Overweight, Obese
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteIran
- Study dates
- Apr 2015to Jun 2017
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diabetic female patient with 6.5<H1AC<7.2.
- Monotherapy with Metformin.
- 18-45 years of age.
- Body mass index (BMI) between 27-35 kg/ m².
- Consume DBs regularly during their habitual diet.
- Must be able to have moderate exercise.
- Must be interested to have weight loss.
Who cannot join
- Participating in a research project involving weight loss or physical activity in the previous six months.
- Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
- Taking medication that could affect metabolism or change body weight.
- Report heart problems, chest pain, and cancer within the last five years.
- Unwilling to change intake of beverages during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Replacing Diet Beverages With Water on Type 2 Diabetic Obese Females Attending a Weight Loss Program - a Randomized, 24 Week Clinical Trial
the present study aimed to follow up our participants in order to consider the changes in weight and anthropometric measurements after the 12-month weight maintenance as well as the total of 18 months, consisting of the previously described 24 weeks active weight loss and a further 53 weeks weight maintenance. The secondary outcome was to compare the abdominal adiposity, carbohydrate, and lipid metabolism during these periods.
- Conditions
- Type 2 Diabetes, Overweight, Obese
- Being tested
- DBs at the end of the main meal + weight control program, Water at the end of the main meal+ weight control program
- Keywords
- diet beverages, water, diabetes, weight loss, insulin sensitivity
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity, Diabetes Mellitus, Weight Loss, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBs at the end of the main meal + weight control programBehavioural
Subjects are asked to have 250 ml DBs at the end of their lunch as the main meal, while they are on a multidisciplinary diet plan.
Water at the end of the main meal+ weight control programBehavioural
Subjects are asked to have 250 ml water at the end of their lunch as the main meal, while they are on a multidisciplinary diet plan.
| Study group | Role | What they receive |
|---|---|---|
| Diet Beverages | Experimental | 'Diet beverages' after the main meal Receives: Behavioral: DBs at the end of the main meal + weight control program |
| Water | Experimental | 'Water' after the main meal Receives: Behavioral: Water at the end of the main meal+ weight control program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: 77 weeks
Secondary outcomes (6)
Fasting plasma glucose
Measured: 77 weeks
Insulin resistance (HOMA)
Measured: 77 weeks
Lipid profiles
Measured: 77 weeks
Waist circumference
Measured: 77 weeks
BMI
Measured: 77 Weeks
HA1C
Measured: 77 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study startApr 2015
- Primary completionFeb 2017
- Study completionJun 2017
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.
- 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
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novindiet Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham, Tehran University of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Hamid R Farshchi, MD, PhD, Study chair, NovinDiet Clinic, School of Life Sciences, The University of NottinghamAmeneh Madjd, Dr, Principal investigator, NovinDiet Clinic, School of Life Sciences, The University of NottinghamIan A Macdonald, Prof., Principal investigator, School of Life Sciences, The University of NottinghamMoira A Taylor, PhD, Principal investigator, School of Life Sciences, The University of NottinghamReza Malekzadeh, Prof., Principal investigator, Digestive Disease Research Institute, Tehran University of Medical SciencesAlireza Delavari, MD, Principal investigator, Digestive Disease Research Institute, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726762
- Sponsor's protocol ID
- ND-307
- Status last verified
- Oct 2018
- First submitted
- 30 Oct 2018
- Last updated
- 31 Oct 2018
- 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 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Replacing Diet Beverages With Water on Type 2 Diabetic Obese Females Attending a Weight Loss Program - a Randomized, 24 Week Clinical Trial
- ClinicalTrials.gov ID
- NCT03726762
- Acronym / sponsor ID
- ND-307
- Conditions
- Type 2 Diabetes, Overweight, Obese
- Keywords
- diet beverages, water, diabetes, weight loss, insulin sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Novindiet ClinicUniversity, hospital or other
- Collaborators
- University of Nottingham, Tehran University of Medical Sciences
- Study start
- Apr 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 31 Oct 2018 (actual)
- 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 present study aimed to follow up our participants in order to consider the changes in weight and anthropometric measurements after the 12-month weight maintenance as well as the total of 18 months, consisting of the previously described 24 weeks active weight loss and a further 53 weeks weight maintenance. The secondary outcome was to compare the abdominal adiposity, carbohydrate, and lipid metabolism during these periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet Beverages | Experimental | Behavioral: DBs at the end of the main meal + weight control program'Diet beverages' after the main meal |
| Water | Experimental | Behavioral: Water at the end of the main meal+ weight control program'Water' after the main meal |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Diabetic female patient with 6.5<H1AC<7.2.
- Monotherapy with Metformin.
- 18-45 years of age.
- Body mass index (BMI) between 27-35 kg/ m².
- Consume DBs regularly during their habitual diet.
Key exclusion criteria (5 listed)
- Participating in a research project involving weight loss or physical activity in the previous six months.
- Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
- Taking medication that could affect metabolism or change body weight.
- Report heart problems, chest pain, and cancer within the last five years.
- Unwilling to change intake of beverages during the study period.
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 |
|---|---|---|
| DBs at the end of the main meal + weight control programSubjects are asked to have 250 ml DBs at the end of their lunch as the main meal, while they are on a multidisciplinary diet plan. | Behavioural | Diet Beverages |
| Water at the end of the main meal+ weight control programSubjects are asked to have 250 ml water at the end of their lunch as the main meal, while they are on a multidisciplinary diet plan. | Behavioural | Water |
Primary outcome
Weight loss
Time frame: 77 weeks
6 secondary outcomes
Fasting plasma glucose
Time frame: 77 weeks
Insulin resistance (HOMA)
Time frame: 77 weeks
Lipid profiles
Time frame: 77 weeks
Waist circumference
Time frame: 77 weeks
BMI
Time frame: 77 Weeks
HA1C
Time frame: 77 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 31 Oct 2018.
- 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.
Hamid R Farshchi, MD, PhD study chair
NovinDiet Clinic, School of Life Sciences, The University of Nottingham
Ameneh Madjd, Dr principal investigator
NovinDiet Clinic, School of Life Sciences, The University of Nottingham
Ian A Macdonald, Prof. principal investigator
School of Life Sciences, The University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Type 2 Diabetes and Overweight, run by Novindiet Clinic at 1 site in Iran.
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 7 inclusion and 5 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 Oct 2018. 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 Iran. 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?
Weight loss (time frame: 77 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 31 Oct 2018.