NCT03002545

Brief Summary

This study aims to determine how a 12-week magnesium supplementation with 400 mg magnesium from organic magnesium citrate affects blood glucose control and insulin resistance within patients with type 2 diabetes (HbA1c\> 6%) and how the expression of certain Mg-sensitive transporting genes is affected .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

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

December 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

2.2 years

First QC Date

December 19, 2016

Last Update Submit

August 27, 2019

Conditions

Effect of Magnesium in Diabetes

Keywords

MagnesiumType II diabetesmagnesium-sensitive genes

Outcome Measures

Primary Outcomes (3)

  • blood sampling

    measurement of type II Diabetes relevant Parameters including Glucose, HbA1c, HOMA-IR, magnesium-sensitive gene expression

    12 weeks

  • blood pressure measurement

    measurement of blood pressure

    12 weeks

  • questionnaire SF-36

    questionnaire is used to assess the physiological health Status of patients

    12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

identically tasting and looking Placebo

Dietary Supplement: Placebo

Magnesium

ACTIVE COMPARATOR

Supplementation with 400 mg Magnesium from Magnesium citrate once daily

Dietary Supplement: Magnesium citrate

Interventions

Magnesium citrateDIETARY_SUPPLEMENT
Magnesium
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type II Diabetics (HbA1c \> 6%)

You may not qualify if:

  • pregnancy, lactation
  • persons with severe renal impairment (glomerular filtration rate \<30 ml / min)
  • use of insulin, oral antidiabetic drugs, diuretics, antacids or proton pump inhibitors within 4 weeks prior to study start and during the study
  • intake of vitamin supplements, dietary supplements, mineral products or possibly enriched foods containing Magnesium within 4 weeks before study start and during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Anna Hospital

Herne, 44649, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

magnesium citrate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2016

First Posted

December 23, 2016

Study Start

December 1, 2016

Primary Completion

March 1, 2019

Study Completion

July 1, 2019

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

DE(1)