AzTrials
AzTrials

Type 2 DiabetesNCT02412774

Effects of Replacing Diet Beverages With Water on Weight Loss and Plasma Glucose Control in Type 2 Diabetes

A study testing DBs at the end of the main meal + Diet and Water at the end of the main meal+ Diet in people with Type 2 Diabetes and Overweight, run by Novindiet Clinic at 1 site in Iran.

Completed

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

Official record
Search all trials

Trial summary

The purpose of the present study is to evaluate the effect of replacing diet beverages with water on weight loss and biochemical indicators for insulin sensitivity and cardiometabolic risk factors of diabetic obese and overweight female adults when they are in a multidisciplinary weight loss plan. 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
What is being tested?
DBs at the end of the main meal + Diet and Water at the end of the main meal+ Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteIran
Study dates
Apr 2015to Jan 2016
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.

Iran1 site

  • NovinDiet Clinic

    Tehran, 1913635136

Other trials in Iran

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 purpose of the present study is to evaluate the effect of replacing diet beverages with water on weight loss and biochemical indicators for insulin sensitivity and cardiometabolic risk factors of diabetic obese and overweight female adults when they are in a multidisciplinary weight loss plan.

Being tested
DBs at the end of the main meal + Diet, Water at the end of the main meal+ Diet
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 + DietBehavioural

    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 for 24 weeks.

  • Water at the end of the main meal+ DietBehavioural

    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 for 24 weeks.

Study groups in NCT02412774
Study groupRoleWhat they receive
Diet Beverages (DBs)ExperimentalDiet beverages after the main meal+ Diet
Receives: Behavioral: DBs at the end of the main meal + Diet
WaterExperimentalWater after the main meal+ Diet
Receives: Behavioral: Water at the end of the main meal+ Diet

What is being measured

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

  1. Weight loss

    Measured: 24 weeks

Secondary outcomes (6)

  1. Fasting plasma glucose

    Measured: 24 weeks

  2. Insulin resistance (HOMA)

    Measured: 24 weeks

  3. Lipid profiles

    Measured: 24 weeks

  4. Waist circumference

    Measured: 24 weeks

  5. BMI

    Measured: 24 Weeks

  6. HA1C

    Measured: 24 Weeks

Timeline

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

  1. First posted9 Apr 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionOct 2015
  4. Study completionJan 2016

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
Single blind
Who is masked
Outcomes assessor
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02412774
Sponsor's protocol ID
ND-107
Status last verified
Oct 2019
First submitted
6 Apr 2015
Last updated
25 Oct 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Lohner S, Kuellenberg de Gaudry D, Toews I, Ferenci T, Meerpohl JJ. Non-nutritive sweeteners for diabetes mellitus. Cochrane Database Syst Rev. 2020 May 25;5(5):CD012885. doi: 10.1002/14651858.CD012885.pub2.

    PubMed 32449201

Questions about this trial

What is this clinical trial studying?

A study testing DBs at the end of the main meal + Diet and Water at the end of the main meal+ Diet in people with 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 25 Oct 2019. 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: 24 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 NCT02412774, 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 25 Oct 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in