NCT03726762

Brief 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. The secondary outcome was to compare the abdominal adiposity, carbohydrate, and lipid metabolism during these periods.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

1.8 years

First QC Date

October 30, 2018

Last Update Submit

October 30, 2018

Conditions

Type 2 DiabetesOverweightObese

Keywords

diet beverageswaterdiabetesweight lossinsulin sensitivity

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    77 weeks

Secondary Outcomes (6)

  • Fasting plasma glucose

    77 weeks

  • Insulin resistance (HOMA)

    77 weeks

  • Lipid profiles

    77 weeks

  • Waist circumference

    77 weeks

  • BMI

    77 Weeks

  • +1 more secondary outcomes

Study Arms (2)

Diet Beverages

EXPERIMENTAL

'Diet beverages' after the main meal

Behavioral: DBs at the end of the main meal + weight control program

Water

EXPERIMENTAL

'Water' after the main meal

Behavioral: Water at the end of the main meal+ weight control program

Interventions

DBs at the end of the main meal + weight control programBEHAVIORAL

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.

Diet Beverages
Water at the end of the main meal+ weight control programBEHAVIORAL

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.

Water

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diabetic female patient with 6.5\<H1AC\<7.2.
  • Monotherapy with Metformin.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NovinDiet Clinic

Tehran, 1913635136, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2OverweightObesityDiabetes MellitusWeight LossInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesHyperinsulinism

Study Officials

  • Hamid R Farshchi, MD, PhD

    NovinDiet Clinic, School of Life Sciences, The University of Nottingham

    STUDY CHAIR

  • Ameneh Madjd, Dr

    NovinDiet Clinic, School of Life Sciences, The University of Nottingham

    PRINCIPAL INVESTIGATOR

  • Ian A Macdonald, Prof.

    School of Life Sciences, The University of Nottingham

    PRINCIPAL INVESTIGATOR

  • Moira A Taylor, PhD

    School of Life Sciences, The University of Nottingham

    PRINCIPAL INVESTIGATOR

  • Reza Malekzadeh, Prof.

    Digestive Disease Research Institute, Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Alireza Delavari, MD

    Digestive Disease Research Institute, Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2018

First Posted

October 31, 2018

Study Start

April 1, 2015

Primary Completion

February 1, 2017

Study Completion

June 1, 2017

Last Updated

October 31, 2018

Record last verified: 2018-10

Locations

IR(1)